
[Federal Register: February 29, 2008 (Volume 73, Number 41)]
[Notices]               
[Page 11121-11122]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29fe08-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2008-P-0125] (formerly Docket No. 2007P-0172)

 
Determination That MINOCIN (Minocycline Hydrochloride) Capsules 
Equivalent to 75 Milligrams Base Was Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
determination that MINOCIN (minocycline hydrochloride) Capsules 
equivalent to (EQ) 75 milligrams (mg) base was not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDAs) for 
minocycline hydrochloride capsules if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162). Regulations also provide that the 
agency must make a determination as to whether a listed drug was 
withdrawn from sale for reasons of safety or effectiveness before an 
ANDA that refers to that listed drug may be approved (Sec.  
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that 
does not refer to a listed drug.
    On May 1, 2007, Kendle International, on behalf of Aurobindo 
Pharmaceuticals, Ltd., submitted a citizen petition (Docket No. 2007P-
0172/CP1) to FDA under 21 CFR 10.30. The petition requests that the 
agency determine whether MINOCIN

[[Page 11122]]

(minocycline hydrochloride) Capsules EQ 75 mg base (NDA 050-649), 
manufactured by Triax Pharmaceuticals, Ltd. (Triax), was withdrawn from 
sale for reasons of safety or effectiveness. MINOCIN is a tetracycline-
class antibiotic medicine used to treat certain infections caused by 
bacteria. MINOCIN Capsules EQ 75 mg base was approved on February 12, 
2001. Our records show that the 75 mg strength of this product was 
marketed for a short period of time in 2001. MINOCIN Capsules EQ 75 mg 
base were discontinued in September 2001 and the drug product was moved 
from the prescription drug product list to the ``Discontinued Drug 
Product List'' section of the Orange Book.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that MINOCIN Capsules EQ 75 mg base was not withdrawn from 
sale for reasons of safety or effectiveness. The petitioner identified 
no data or other information suggesting that MINOCIN Capsules EQ 75 mg 
base was withdrawn for reasons of safety or effectiveness. FDA has 
independently evaluated relevant literature and data for possible 
postmarketing adverse events and has found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness. Accordingly, the agency will continue to list 
MINOCIN (minocycline hydrochloride) Capsules EQ 75 mg base in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' delineates, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness. ANDAs that refer to minocycline 
hydrochloride capsules EQ 75 mg base may be approved by the agency if 
all other legal and regulatory requirements for the approval of ANDAs 
are met. If FDA determines that labeling for this drug product should 
be revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.

    Dated: February 21, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3879 Filed 2-28-08; 8:45 am]

BILLING CODE 4160-01-S
