
[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Notices]
[Pages 43337-43342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-1975-N-0336 (Formerly 75N-0184), FDA-1975-N-0355 
(Formerly 75N-0185), FDA-1976-N-0272 (Formerly 76N-0056), FDA-1976-N-
0344 (Formerly 76N-0057), FDA-1978-N-0701 (Formerly 78N-0070), FDA-
1979-N-0224 (Formerly 79N-0169), FDA-1983-N-0297 (Formerly 83N-0030), 
and FDA-1988-N-0004 (Formerly 88N-0242); DESI 597, 1626, 3265, 10837, 
12283, and 50213, and Hydrocortisone Acetate and Pramoxine 
Hydrochloride]


Drugs for Human Use; Drug Efficacy Study Implementation; Certain 
Prescription Drugs Offered for Various Indications; Opportunity To 
Affirm Outstanding Hearing Request

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is offering an 
opportunity to affirm outstanding hearing requests pertaining to 
several dockets. FDA will assume that companies with outstanding 
hearing requests that do not respond to this notice are no longer 
interested in pursuing their requests, and will deem the requests 
withdrawn.

DATES: Effective Date: This notice is effective August 23, 2012.
    Hearing Requests: Hearing requests must be affirmed by notifying 
FDA by August 23, 2012. Hearing requests not affirmed within that 
timeframe will be deemed withdrawn.

ADDRESSES: Requests to affirm or withdraw outstanding hearing requests, 
as well as all other communications in response to this notice, should 
be identified with the appropriate docket number, and directed to 
Pamela Lee, Office of Unapproved Drugs and Labeling Compliance, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, rm. 5173, Silver Spring, MD 20993-0002.

[[Page 43338]]


FOR FURTHER INFORMATION CONTACT: Pamela Lee, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 5173, Silver Spring, MD 20993-0002, 301-796-3297, email: 
pamela.lee@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is 
offering an opportunity to affirm outstanding hearing requests 
pertaining to FDA Docket Nos. FDA-1975-N-0336 (formerly 75N-0184) (DESI 
597); FDA-1976-N-0272 (formerly 76N-0056), FDA-1976-N-0344 (formerly 
76N-0057), and FDA-1978-N-0701 (formerly 78N-0070) (DESI 1626); FDA-
1975-N-0355 (formerly 75N-0185) (DESI 3265); FDA-1975-N-0336 (formerly 
75N-0184) (DESI 10837); FDA-1979-N-0224 (formerly 79N-0169) (DESI 
12283); FDA-1983-N-0297 (formerly 83N-0030) (DESI 50213); and FDA-1988-
N-0004 (formerly 88N-0242).

I. Background

    When initially enacted in 1938, the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) required that ``new drugs'' (see 21 U.S.C. 
321(p)) be approved for safety by FDA before they could legally be sold 
in interstate commerce. To this end, the FD&C Act made it the sponsor's 
responsibility, before marketing a new drug, to submit a new drug 
application (NDA) to FDA to prove that its drug was safe. Between 1938 
and 1962, if a drug obtained approval, FDA considered drugs that were 
identical, related, or similar (IRS) (see (21 CFR 310.6(b)(1)) to the 
approved drug to be ``covered'' by that approval, and allowed those IRS 
drugs to be marketed without independent approval.
    In 1962, Congress amended the FD&C Act to require that new drugs be 
proven effective for their labeled indications, as well as safe, to 
obtain FDA approval. This amendment also necessitated that FDA conduct 
a retrospective evaluation of the effectiveness of the drug products 
that FDA had approved as safe between 1938 and 1962. FDA contracted 
with the National Academy of Sciences/National Research Council (NAS/
NRC) to make an initial evaluation of the effectiveness of over 3,400 
products that had been approved only for safety between 1938 and 1962. 
The NAS/NRC reports for these drug products were submitted to FDA in 
the late 1960s and early 1970s. The Agency reviewed and reevaluated the 
reports and published its findings in Federal Register notices. FDA's 
administrative implementation of the NAS/NRC reports was called the 
Drug Efficacy Study Implementation (DESI). DESI covered the 
approximately 3,400 products specifically reviewed by the NAS/NRC, as 
well as the even larger number of IRS products that entered the market 
without FDA approval.
    All drugs covered by the DESI review are ``new drugs'' under the 
FD&C Act. If FDA's final DESI determination classifies a drug product 
as lacking substantial evidence of effectiveness for one or more 
indications, that drug product and those IRS to it may no longer be 
marketed for the indications and are subject to enforcement action as 
unapproved new drugs. If FDA's final DESI determination classifies the 
drug product as effective for one or more of its labeled indications, 
the drug can be marketed for those indications, provided it is the 
subject of an application approved for safety and effectiveness. 
Sponsors of drug products that have been found to be effective for one 
or more indications through the DESI process may rely on FDA's 
effectiveness determinations, but typically must update their labeling 
to conform to the indications found to be effective by FDA and to 
include any additional safety information required by FDA. Those drug 
products with NDAs approved before 1962 for safety therefore require 
approved supplements to their original applications if found to be 
effective under DESI; IRS drug products require an approved NDA or 
abbreviated new drug application (ANDA), as appropriate. Furthermore, 
labeling for drug products classified as effective may contain only 
those indications for which the review found the product effective 
unless the firm marketing the product has received an approval for the 
additional indication(s).

II. Outstanding Hearing Requests Pertaining to Docket Nos. FDA-1975-N-
0336 (Formerly 75N-0184) (DESI 597); FDA-1976-N-0272 (Formerly 76N-
0056), FDA-1976-N-0344 (Formerly 76N-0057), and FDA-1978-N-0701 
(Formerly 78N-0070) (DESI 1626); FDA-1975-N-0355 (Formerly 75N-0185) 
(DESI 3265); FDA-1975-N-0336 (Formerly 75N-0184) (DESI 10837); FDA-
1979-N-0224 (Formerly 79N-0169) (DESI 12283); FDA-1983-N-0297 (Formerly 
83N-0030) (DESI 50213); and FDA-1988-N-0004 (Formerly 88N-0242)

    In 2006, FDA announced a new drug safety initiative to address 
unapproved drugs currently being marketed in the United States, and to 
facilitate a rational process to bring all such unapproved drugs into 
the approval process. As part of the Unapproved Drugs Initiative, the 
Office of Compliance of the Center for Drug Evaluation and Research is 
reviewing proceedings that remain open under DESI. According to FDA's 
records, the dockets discussed in this document contain pending hearing 
requests.
    This Federal Register notice identifies the products that are the 
subjects of hearing requests to the extent possible based on the 
information contained in the hearing requests. In some cases, the 
companies requesting hearings identified the product that was the 
subject of the hearing request by name. In other cases, the company 
simply identified the subject of its hearing request as a product that 
is IRS to one of the products reviewed under DESI. In yet other cases, 
there is no information provided by the requester about the product 
that is the subject of its hearing request.
    In cases where FDA was able to obtain current contact information 
for a company (or its successor-in-interest) or its representative, FDA 
sent letters directly to the companies (or their successors-in-
interest) and/or their representatives requesting that outstanding 
hearing requests be withdrawn or affirmed within a specified timeframe. 
In some cases, however, FDA was unable to find current contact 
information for the companies that requested hearings. Because many of 
the products that are the subjects of these hearing requests may no 
longer be marketed and some of the companies that requested hearings 
may no longer be in business, FDA is seeking to determine whether there 
is continued interest in pursuing these outstanding hearing requests. 
It should be noted that the discussion of DESI dockets does not provide 
a comprehensive historical record of each docket and, therefore, will 
not identify every request that had been previously addressed.
    Through this Federal Register notice, FDA seeks to have any company 
with an outstanding hearing request covered by this notice that has not 
already responded to a direct communication from FDA either withdraw or 
affirm its hearing request. FDA will assume that companies with 
outstanding hearing requests that do not respond to this notice are no 
longer in business and/or do not have a continuing interest in the 
hearings, and FDA will deem their requests withdrawn.
    To withdraw an outstanding hearing request, a company (or its 
successor-in-interest) or its representative should send a letter 
stating its intention to do so to Pamela Lee (see ADDRESSES). The 
letter should include the docket number of the proceeding, as well as 
the name

[[Page 43339]]

and National Drug Code (NDC) number of the product that is the subject 
of the hearing request.
    To affirm an outstanding hearing request, a company (or its 
successor-in-interest) or its representative should send a letter 
stating its intention to do so to Pamela Lee (see ADDRESSES). The 
letter should include the docket number of the proceeding, as well as 
the name and NDC number of the product that is the subject of the 
hearing request. Letters affirming outstanding hearing requests must be 
postmarked or emailed by the date specified in this notice (see DATES). 
Only currently outstanding hearing requests may be affirmed; this 
notice does not provide a new opportunity to request a hearing under 
any of these dockets.

A. Certain Drug Products Containing an Anticholinergic in Combination 
With a Barbituate; Docket No. FDA-1975-N-0336 (Formerly 75N-0184) (DESI 
597)

    Under Docket No. FDA-1975-N-0336 (formerly 75N-0184), FDA 
determined that certain drug products containing an anticholinergic in 
combination with a barbiturate lacked substantial evidence of 
effectiveness for various gastrointestinal disorders, and offered an 
opportunity for hearing regarding its conclusion (48 FR 20495, May 6, 
1983). In response to the May 1983 notice, the following companies 
filed timely hearing requests: A.H. Robins Co. (now part of Pfizer, 
Inc., 235 East 42nd St., New York, NY 10017), regarding Donnatal 
Tablets (ANDA 86-676), Capsules (ANDA 86-677), and Elixir (ANDA 86-
661); B.F. Ascher & Co., Inc., 15501 W. 109th St., Lenexa, KS 66219, 
regarding Anaspaz-PB; Bay Laboratories, Inc., 3654 West Jarvis, Skokie, 
IL 60076, regarding Bay-Ase Elixir (ANDA 86-673); Beecham Laboratories, 
a Division of Beecham, Inc. (now part of Glaxo SmithKline, 200 N 16th 
St., 1, Philadelphia, PA 19102), regarding Hybephen (ANDA 86-
573); Carter-Wallace, Inc. (now part of Meda Pharmaceuticals, Inc., 265 
Davidson Ave., Suite 300, Somerset, NJ 08873-4120), regarding 
Barbidonna Tablets (ANDA 86-589), Barbidonna Elixir (ANDA 86-590), and 
Barbidonna No. 2 Tablets (ANDA 87-572); Ferndale Laboratories, Inc. 
(now part of Ferndale Pharma Group, Inc., 780 W. Eight Mile Rd., 
Ferndale, MI 48220), regarding Bellkatal Tablets and Pheno-Bella 
Tablets; Halsey Drug Co., Inc. (now part of Acura Pharmaceuticals, 
Inc., 616 N. North Court, Suite 120, Palatine, IL 60067), regarding 
Susano Elixir (ANDA 86-587) and Susano Tablets (ANDA 86-588); Kremers-
Urban Co. (now part of Kremers-Urban Pharmaceuticals, Inc., 902 
Carnegie Center, Suite 360, Princeton, NJ 08540), regarding Levsin with 
Phenobarbital Tablets (ANDA 86-640); Lemmon Co. (now part of Teva 
Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 
19454-1090), regarding Belladonna Alkaloids and Phenobarbital Tablets 
(ANDA 86-591); McNeil Pharmaceutical (now part of Ortho-McNeil-Janssen 
Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., P.O. Box 200, 
Titusville, NJ 08568), regarding Butibel Tablets and Butibel Elixir 
(ANDA 86-664); National Pharmaceutical Manufacturing Co. (now part of 
Actavis US, 60 Columbia Rd., Bldg. B, Morristown, NJ 07960), regarding 
Barophen Elixir (ANDA 86-546) and Butabar Belladonna Elixir (ANDA 86-
561); Purepac Pharmaceutical (now part of Actavis US, 60 Columbia Rd., 
Bldg. B, Morristown, NJ 07960), regarding Belladonna Alkaloids with 
Phenobarbital Tablets and Elixir; Reid-Provident Laboratories, Inc. 
(now part of Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL 
60064-3500), regarding Spalix Elixir (ANDA 86-652) and Spalix Tablets 
(ANDA 86-653); Richlyn Laboratories, Inc. (now part of Impax 
Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544), regarding 
Bellophen (ANDA 86-687) and Spasmolin (ANDA 86-655); Sandoz, Inc., 506 
Carnegie Center, Suite 400, Princeton, NJ 08540, regarding Belladenal 
Tablets (ANDA 86-668) and Belladenal S Tablets (ANDA 87-198); Stuart 
Pharmaceuticals, Division of ICI Americas, Inc. (now part of 
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 15437, 
Wilmington, DE 19850-5437), regarding Kinesed Tablets; Vale Chemical 
Co., Inc., 1201 Liberty St., Allentown, PA 18102, regarding Barbeloid 
Tablets, Green (NDA 85-532) and Barbeloid Tablets, Yellow (NDA 86-549); 
West-ward Pharmaceutical Corp., 401 Industrial Way West, Eatontown, NJ 
07724-2206, regarding Belladonna Alkaloid with Phenobarbital Tablets; 
William P. Poythress & Co., Inc., 16 N. 22nd St., P.O. Box 26946, 
Richmond, VA 23261, regarding unidentified products composed of 
atropine sulfate 0.195 milligrams (mg) in combination with 
phenobarbital 16 mg; William Rorer, Inc. (now part of Sanofi-Aventis 
U.S., 55 Corporate Dr., Bridgewater, NJ 08807), regarding Chardonna-2 
Tablets (ANDA 86-585); and Wharton Laboratories, Inc., 48th Ave., Long 
Island City, NY 11101, regarding Bellastal Capsules (ANDA 86-657).
    In May, June, and July 2011, FDA sent letters to the following 
companies requesting that they withdraw or affirm their outstanding 
hearing requests under this docket within 30 days: Pfizer, Inc.; B.F. 
Ascher & Co., Inc.; Glaxo SmithKline; Meda Pharmaceuticals, Inc.; 
Ferndale Pharma Group, Inc.; Acura Pharmaceutical Co.; Kremers-Urban 
Pharmaceuticals, Inc.; Teva Pharmaceuticals; Ortho-McNeil-Janssen 
Pharmaceuticals, Inc.; Actavis US; Abbott Laboratories; Impax 
Laboratories, Inc.; Sandoz, Inc.; AstraZeneca Pharmaceuticals LP; West-
ward Pharmaceutical Corp.; and Sanofi-Aventis U.S.
    On May 24, 2011, Actavis US withdrew the hearing request filed by 
National Pharmaceutical Manufacturing Co. On May 26, 2011, Teva 
Pharmaceuticals and Impax Laboratories, Inc., withdrew the hearing 
requests filed by Lemmon Co. and Richlyn Laboratories, Inc., 
respectively. On June 2, 2011, Ferndale Pharma Group, Inc., withdrew 
its hearing request. On June 3, 2011, AstraZeneca Pharmaceuticals, LP, 
withdrew the hearing request filed by Stuart Pharmaceuticals. On June 
6, 2011, Acura Pharmaceutical Co. withdrew the hearing request filed by 
Halsey Drug Co., Inc. On June 7, 2011, Johnson & Johnson Pharmaceutical 
Research & Development, LLC, responded to the letter sent to Ortho-
McNeil-Janssen Pharmaceuticals, Inc., stating that the rights to 
Butibel Elixir had been transferred to Carter Wallace in 1982. On June 
20, 2011, B.F. Ascher & Co., Inc., withdrew its hearing request. On 
June 22, 2011, Novartis Pharmaceuticals Corp., the successor-in-
interest by merger to Sandoz, Inc., withdrew Sandoz, Inc.'s hearing 
request. On July 7, 2011, Meda Pharmaceuticals, Inc., withdrew the 
hearing request filed by Carter-Wallace, Inc., as well as the hearing 
request filed by McNeil Pharmaceutical for Butibel Tablets and Elixir. 
On July 27, 2011, Kremers-Urban Co. withdrew its hearing request. On 
August 11, 2011, GlaxoSmithKline withdrew the hearing request filed by 
Beecham Laboratories. On August 24, 2011, Abbott Laboratories withdrew 
the hearing request filed by Reid-Provident Laboratories, Inc.
    On July 6, 2011, West-ward Pharmaceutical Corp. affirmed its 
hearing request and PBM Pharmaceuticals, Inc., affirmed the hearing 
request filed by A.H. Robins Co., as the asserted successor-in-interest 
to A.H. Robins Co.'s hearing request. A Federal Register notice issued 
on June 8, 2011 (76 FR 33310), withdrew the approval of 70 NDAs and 97 
ANDAs. This included the withdrawal of the approval for Donnatal 
Capsules and

[[Page 43340]]

withdrawal of the conditional approval for the Donnatal Tablets and 
Elixir. This withdrawal notice was subsequently corrected to note that 
the approval and conditional approvals for these products were still in 
effect, because PBM Pharmaceuticals, Inc., had acquired the rights to 
the ANDAs and had informed FDA before the withdrawal would have become 
effective that it did not want the ANDAs withdrawn (76 FR 79701, 
December 22, 2011).
    As of April 1, 2012, Actavis U.S. (with respect to the hearing 
request filed by Purepac Pharmaceutical) and Sanofi-Aventis U.S. had 
not responded to FDA. FDA was unable to find current contact 
information for Bay Laboratories, Inc.; Vale Chemical Co., Inc.; 
William P. Poythress & Co., Inc.; and Wharton Laboratories, Inc. If any 
of these companies, or any successor-in-interest, continues to have an 
interest in pursuing its hearing request under this docket, the 
companies (or their successors-in-interest) must affirm their hearing 
requests in writing by the date specified in this notice (see DATES). 
FDA will assume that hearing requests that are not affirmed within that 
timeframe are no longer being pursued, and will deem them withdrawn.

B. Combination Drugs Containing a Xanthine Derivative; Docket No. FDA-
1976-N-0272 (Formerly 76N-0056), FDA-1976-N-0344 (Formerly 76N-0057), 
and FDA-1978-N-0701 (Formerly 78N-0070) (DESI 1626)

    In 1972, FDA classified certain combination drug products 
containing a xanthine derivative as less than effective for some 
labeled indications and possibly effective for other labeled 
indications (37 FR 14895, July 26, 1972). As described in a Federal 
Register notice of February 29, 1984, FDA subsequently handled these 
products in three groups: (1) Combinations containing more than 2 
grains of xanthine derivative, more than 8 mg of phenobarbital, and/or 
an ingredient not considered as part of the over-the-counter (OTC) drug 
review (Docket No. FDA-1976-N-0272 (formerly 76N-0056)); (2) 
combinations containing 2 grains or less of a xanthine derivative, 
ephedrine, and 8 mg or less of phenobarbital (Docket No. FDA-1976-N-
0344 (formerly 76N-0057)); and (3) combinations containing 
theophylline, ephedrine, and hydroxyzine hydrochloride (HCl) (Docket 
No. FDA-1978-N-0701 (formerly 78N-0070)) (49 FR 7454, February 29, 
1984).
    In 1976, FDA reclassified certain combination preparations 
containing a xanthine derivative to lacking substantial evidence of 
effectiveness, proposed withdrawing associated NDAs, and offered an 
opportunity for hearing regarding its proposal (41 FR 15051, April 9, 
1976). The group of products addressed in the April 1976 notice 
contained more than 2 grains of xanthine derivative, a barbiturate in 
higher strength than the equivalent of 8 mg of phenobarbital, and/or an 
ingredient not considered as part of the OTC drug review (Docket No. 
FDA-1976-N-0272 (formerly 76N-0056)) (id.). The holders of the NDAs 
listed in the April 1976 notice did not request hearings, and those 
NDAs were withdrawn in October 1977 (42 FR 54620, October 7, 1977). 
However, in response to the April 1976 notice, the following companies 
filed timely hearing requests: Knoll Pharmaceutical Co. (now part of 
Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL 60064-3500), 
regarding Quadrinal Tablets and Suspension, and Mead Johnson 
Laboratories (now Mead Johnson Nutrition, 4th Floor, 2701 Patriot 
Blvd., Glenview, IL 60026), regarding Quibron Plus Capsules and Elixir.
    In 1984, FDA amended the April 1976 notice to include its analysis 
of new information regarding combination products containing a xanthine 
derivative (49 FR 7454, February 29, 1984). Based on its analysis of 
the new information, FDA concluded that there is a lack of substantial 
evidence that: (1) Each ingredient contributes to the claimed effect of 
such combination drug products, and (2) the dosage of each component is 
such that the combinations are safe and effective for a significant 
patient population (id.). Therefore, FDA proposed in the 1984 notice to 
withdraw approval of the applications for combination products 
containing a xandine derivative, and offered an opportunity for hearing 
regarding its proposal. In response to the February 1984 notice, the 
following companies filed timely hearing requests: National 
Pharmaceutical Manufacturing Co. (now part of Actavis US, 60 Columbia 
Rd., Bldg. B, Morristown, NJ 07960), regarding Brondelate Elixir, 
Ferdinal Suspension, Guiaphed Elixir, Hydroxyzine Compound Syrup, 
Iophylline Elixir, Isolate Compound Elixir, and Theofed Suspension and 
Liquid; Warner Lambert Co. (now part of Pfizer, Inc., 235 East 42nd 
St., New York, NY 10017), regarding Tedral SA; and William P. Poythress 
& Co., Inc., 16 N. 22nd St., P.O. Box 26946, Richmond, VA 23261, 
regarding an unidentified product containing a xanthine derivative, 
ephedrine, and 8 mg or less of phenobarbital.
    In March and April 2011, FDA sent letters to Abbott Laboratories, 
Actavis US, Mead Johnson Nutrition, and Pfizer, Inc., requesting that 
these companies withdraw or affirm their outstanding hearing requests 
under this docket within 30 days.
    On April 25, 2011, Mead Johnson Nutrition withdrew the hearing 
request filed by Mead Johnson Laboratories. On May 3, 2011, Pfizer, 
Inc. withdrew the hearing request filed by Warner Lambert Co. On May 9, 
2011, Actavis US withdrew the hearing request filed by National 
Pharmaceutical Manufacturing Co. On June 21, 2011, Abbott Laboratories 
withdrew the hearing request filed by Knoll Pharmaceutical Co.
    FDA was unable to find current contact information for William P. 
Poythress & Co. If this company, or its successor-in-interest, 
continues to have an interest in pursuing its hearing request under 
this docket, the company (or its successor-in-interest) must affirm its 
hearing request in writing by the date specified in this notice (see 
DATES). FDA will assume that hearing requests that are not affirmed 
within that timeframe are no longer being pursued, and will deem them 
withdrawn.

C. Certain Single Entity Antispasmodic Drugs; Docket No. FDA-1975-N-
0355 (Formerly 75N-0185) (DESI 3265)

    In 1971, FDA published DESI efficacy findings for single-ingredient 
anticholinergic drugs for oral or injectable use containing dicyclomine 
HCl and piperidolate HCl, among other ingredients (36 FR 11754, June 
18, 1971). In a notice published on November 11, 1975 (40 FR 52644), 
FDA determined that the June 18, 1971, Federal Register notice should 
not have included drugs containing certain specified ingredients, 
including dicyclomine HCl and piperidolate HCl, because the drugs 
containing those ingredients were not anticholinergic drugs. Also on 
November 11, 1975, FDA published a notice of opportunity for hearing 
regarding these drugs (40 FR 52649). In response to the November 1975 
notice, the following companies filed timely hearing requests: Carnrick 
Laboratories, Inc., 65 Horsehill Rd., Cedar Knolls, NJ 07927, regarding 
Midrin, and Merrell-National Laboratories, 110 Amity Rd., Cincinnati, 
OH 45215, regarding Bentyl Capsules (NDA 7-409), Bentyl Injection (NDA 
8-370), Bentyl Syrup (NDA 7-961), and Dactil Tablets (NDA 8-907).
    In September 2011, FDA sent letters to counsel for Carnrick 
Laboratories, Inc., which FDA believed operated as a subsidiary of Elan 
Corporation PLC, and

[[Page 43341]]

to Sanofi-Aventis U.S., which FDA believes to be the successor-in-
interest to Merrell-National Laboratories. In September 2011, Carnrick 
Laboratories, Inc.'s former counsel informed FDA that it did not 
represent Carnrick Laboratories, Inc., or Elan Corporation PLC with 
respect to the hearing request under DESI 3265. In October 2011, FDA 
sent a letter to Sun Pharmaceutical Industries, Inc., believing it to 
be the successor-in-interest to Carnrick Laboratories, Inc.'s hearing 
request. On November 3, 2011, a representative from Sun Pharmaceutical 
Industries, Inc., verbally informed FDA that it was withdrawing the 
hearing request filed by Carnrick Laboratories, Inc., and stated they 
would be submitting their withdrawal of the hearing request in writing.
    As of April 1, 2012, Sanofi-Aventis U.S. has not responded to FDA. 
If this company, or the successor-in-interest, continues to have an 
interest in pursuing the hearing request filed by Merrell-National 
Laboratories under this docket, the company (or its successor-in-
interest) must affirm the hearing request in writing by the date 
specified in this notice (see DATES). FDA will assume that hearing 
requests that are not affirmed within that timeframe are no longer 
being pursued, and will deem them withdrawn.

D. Certain Anticholinergics/Antispasmodics in Combination With a 
Sedative, and Single-Entity Antispasmodics, in Conventional Dosage 
Form; Docket No. FDA-1975-N-0336 (Formerly 75N-0184) (DESI 10837)

    Through DESI review, FDA determined that two products, Pathibamate 
and Milpath Tablets, both containing tridihexethyl chloride and 
meprobamate, were possibly effective as adjunctive therapy in peptic 
ulcer and in the irritable bowel syndrome, functional diarrhea, drug-
induced diarrhea, ulcerative colitis, urinary bladder spasm, and 
urethral spasm (36 FR 11875, June 22, 1971). In 1981, FDA reclassified 
these products to lacking substantial evidence of effectiveness, 
proposed withdrawing associated NDAs, and offered an opportunity for 
hearing regarding its proposal (46 FR 3977, January 16, 1981). In 
response to the January 1981 notice, the following companies filed 
timely hearing requests: Cord Laboratories (now part of Sandoz, Inc., 
2555 West Midway Blvd., Broomfield, CO 80020), regarding Chlordinium 
Capsules (ANDA 86-667); Roche Laboratories (now part of Genentech, 
Inc., 1 DNA Way, South San Francisco, CA 94080-4990), regarding Librax; 
and Premo Pharmaceutical Laboratories, Inc. (now part of Teva 
Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 
19454-1090), regarding Meprohex 200 (ANDA 86-674), Meprohex 400 (ANDA 
86-658), and chlordinium capsules (ANDA 86-667).
    FDA sent letters to Genentech, Inc., in November 2010, and to 
Sandoz, Inc., and counsel of record for Premo Pharmaceutical 
Laboratories, Inc., in January 2011, requesting that these companies 
withdraw or affirm their outstanding hearing requests under this docket 
within 30 days. At the time, FDA was unable to find a current address 
for Premo Pharmaceutical Laboratories, Inc., and did not know that the 
company is part of Teva Pharmaceuticals.
    On February 4, 2011, Genentech, Inc., informed FDA that it was no 
longer interested in pursuing the hearing request filed by Roche 
Laboratories, but noted that it had sold the rights of the product that 
was the subject of the hearing request to Valeant Pharmaceuticals 
International, Inc. On February 28, 2011, Sandoz, Inc., withdrew the 
hearing request filed by Cord Laboratories. On March 15, 2011, Teva 
Pharmaceuticals withdrew the hearing request filed by Premo 
Pharmaceutical Laboratories, Inc.
    In March 2011, FDA sent a letter to Valeant Pharmaceuticals 
International, Inc., requesting that the company withdraw or affirm the 
outstanding hearing request filed by Roche Laboratories under this 
docket within 30 days. As of April 1, 2012, Valeant Pharmaceuticals 
International, Inc., had not responded to FDA. If this company, or its 
successor-in-interest, continues to have an interest in pursuing its 
hearing request under this docket, the company (or its successor-in-
interest) must affirm its hearing request in writing by the date 
specified in this notice (see DATES). FDA will assume that hearing 
requests that are not affirmed within that timeframe are no longer 
being pursued, and will deem them withdrawn.

E. Chlorthalidone; Docket No. FDA-1979-N-0224 (Formerly 79N-0169) (DESI 
12283)

    In 1979, as part of the DESI review, FDA announced its conclusions 
regarding the effectiveness of chlorthalidone for the treatment of 
hypertension and certain types of edema (44 FR 54124, September 18, 
1979). Specifically, FDA determined that there was substantial evidence 
to support the effectiveness of the 25- and 50-mg strengths for use in 
hypertension, but that there was no longer justification for the 100-mg 
dosage form of chlorthalidone because of safety concerns at that dosage 
level (id. at 54126). The 1979 notice proposed to withdraw approval of 
the 100-mg strength and offered an opportunity for hearing regarding 
its proposal. In response to the 1979 notice, the following companies 
filed timely hearing requests: Generics International Division of 
Apotex, Inc., 2400 North Commerce Pkwy., suite 400, Weston, FL 33326, 
regarding Chlorthalidone, and USV Pharmaceutical Corp. (now part of 
Sanofi-Aventis U.S., 55 Corporate Dr., Bridgewater, NJ 08807), 
regarding Hygroton (NDA 12-283).
    FDA sent letters to Sanofi-Aventis U.S. and Apotex, Inc., in May 
2011 and July 2011, respectively, requesting that the companies 
withdraw or affirm their outstanding hearing requests under this docket 
within 30 days.
    On August 12, 2011, Sanofi-Aventis U.S. withdrew the outstanding 
hearing request filed by USV Pharmaceutical Corp. As of April 1, 2012, 
Apotex, Inc., had not responded to FDA. If this company, or its 
successor-in-interest, continues to have an interest in pursuing its 
hearing request under this docket, the company (or its successor-in-
interest) must affirm its hearing request in writing by the date 
specified in this notice (see DATES). FDA will assume that hearing 
requests that are not affirmed within that timeframe are no longer 
being pursued, and will deem them withdrawn.

F. Chlortetracycline and Tetracycline; Docket No. FDA-1983-N-0297 
(Formerly 83N-0030) (DESI 50213)

    Through DESI review, FDA determined that certain fixed-combination 
drugs containing antibiotics and sulfonamides lack substantial evidence 
of effectiveness (34 FR 6008, April 2, 1969). The April 1969 Federal 
Register notice proposed to revoke provisions for certification of 
these products and offered interested persons 30 days to submit data 
concerning the proposal. Data submitted in response to the April 1969 
notice did not provide substantial evidence of effectiveness, so FDA 
amended the antibiotic regulations on June 30, 1970, by revoking 
provisions for the certification of these drugs (35 FR 10587, June 30, 
1970). The order was to become effective in 40 days, and allowed 30 
days for interested persons to file objections and request a hearing. 
The time for responding to the June 1970 order was subsequently 
extended until August 17, 1970 (35 FR 12653, August 8, 1970).
    In response to the June 1970 order, Pfizer, Inc., submitted data 
regarding its

[[Page 43342]]

affected product, Urobiotic 250 Capsules, and requested a hearing. 
Despite the filing of timely objections, the amendments were 
inadvertently not stayed, and succeeding codifications of the 
antibiotic regulations did not explicitly provide for certification of 
Urobiotic 250 Capsules. However, FDA permitted Pfizer, Inc., to 
continue distribution of its product pending resolution of the firm's 
hearing request. In July 2010, Pfizer, Inc., voluntarily withdrew its 
application for Urobiotic (see 75 FR 42455, July 21, 2010), but its 
hearing request remains pending.
    In October 2010, FDA sent Pfizer, Inc., a letter requesting that it 
withdraw or affirm its outstanding hearing request under this docket 
within 30 days. As of April 1, 2012, Pfizer, Inc., had not responded to 
FDA. If Pfizer, Inc. (or its successor-in-interest), continues to have 
an interest in pursuing its hearing request under this docket, the 
company (or its successor-in-interest) must affirm its hearing request 
in writing by the date specified in this notice (see DATES). FDA will 
assume that hearing requests that are not affirmed within that 
timeframe are no longer being pursued, and will deem them withdrawn.

G. Hydrocortisone Acetate and Pramoxine HCl; Docket No. FDA-1988-N-0004 
(Formerly 88N-0242)

    Through DESI review, FDA determined that topical corticosteroids, 
including hydrocortisone acetate, were effective for symptomatic relief 
and adjunctive management of various steroid-responsive dermatoses (36 
FR 7982, April 28, 1971). In the mid-1970s, FDA approved several 
products under ANDAs listing hydrocortisone acetate as their sole 
active ingredient. Subsequently, FDA determined that these products 
also contained an anesthetic active ingredient, pramoxine HCl. FDA 
evaluated the effectiveness of the fixed-combination and found no 
evidence that the pramoxine HCl component contributes an effect to the 
combination drug (53 FR 25013, July 1, 1988). Thus, FDA proposed to 
withdraw the ANDAs for these products and offered an opportunity for 
hearing on its proposal (id).
    In response to the July 1988 notice, the following companies filed 
timely hearing requests: Copley Pharmaceutical, Inc., 398 West Second 
St., Boston, MA 02127, regarding a topical aerosol foam hydrocortisone 
and pramoxine HCl product (ANDA 89-440); Ferndale Laboratories, Inc. 
(now part of Ferndale Pharma Group, Inc., 780 W. Eight Mile Rd., 
Ferndale, MI 48220), regarding Pramosone lotion (0.5% hydrocortisone 
acetate) (ANDA 83-213), Pramosone cream (0.5% hydrocortisone acetate) 
(ANDA 83-778), Pramosone cream (1.0% hydrocortisone acetate) (ANDA 85-
368), Pramosone lotion (1.0% hydrocortisone acetate) (ANDA 85-979), 
Pramosone lotion (2.5% hydrocortisone acetate) (ANDA 85-980), Pramosone 
ointment (1% hydrocortisone acetate), Pramosone ointment (2.5% 
hydrocortisone acetate), Pramosone cream (2.5% hydrocortisone acetate), 
Enzone cream, Zone-A lotion, Zone-A Forte lotion, Zone-A cream, FEP 
cream, Dibucort cream, and Procto-cream HC; and Reed & Carnrick (now 
part of Meda Pharmaceuticals, Inc., 265 Davidson Ave., suite 300, 
Somerset, NH 08873-4120), regarding its topical aerosol foam 
hydrocortisone and pramoxine HCl products (ANDAs 86-195 and 86-457).
    In November 2010, FDA sent letters to Copley Pharmaceutical, Inc.; 
Ferndale Pharma Group, Inc.; and Meda Pharmaceuticals, Inc., requesting 
that these companies (or their successors-in-interest) withdraw or 
affirm their outstanding hearing requests under this docket within 30 
days. On January 3, 2011, counsel for Ferndale Laboratories, Inc., and 
Meda Pharmaceutical, Inc., sent a letter affirming the hearing requests 
made by both companies.
    As of April 1, 2012, Copley Pharmaceutical, Inc., had not responded 
to FDA. If this company (or its successor-in-interest) continues to 
have an interest in pursuing its hearing request under this docket, the 
company (or its successor-in-interest) must affirm its hearing request 
in writing by the date specified in this notice (see DATES). FDA will 
assume that hearing requests that are not affirmed within that 
timeframe are no longer being pursued, and will deem them withdrawn.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (sections 502 and 505 (21 U.S.C. 352 and 355)).

    Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18015 Filed 7-23-12; 8:45 am]
BILLING CODE 4160-01-P


