[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Page 65986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25946]



[[Page 65986]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4590]


Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of 
Approval of 21 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 21 abbreviated new drug applications (ANDAs) 
from multiple applicants. The applicants notified the Agency in writing 
that the drug products were no longer marketed and requested that the 
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 2, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The 
applicants listed in the table have informed FDA that these drug 
products are no longer marketed and have requested that FDA withdraw 
approval of the applications under the process described in Sec.  
314.150(c) (21CFR 314.150(c)). The applicants have also, by their 
requests, waived their opportunity for a hearing. Withdrawal of 
approval of an application or abbreviated application under Sec.  
314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                 Drug               Applicant
------------------------------------------------------------------------
ANDA 040759..................  Phenytoin Sodium      Morton Grove
                                Capsules,             Pharmaceuticals,
                                30milligrams (mg)     Inc., 6451 Main
                                (Extended).           St., Morton Grove,
                                                      IL 60053.
ANDA 062349..................  Nystatin Oral         G&W Laboratories,
                                Suspension, 100,000   Inc., 301 Helen
                                units/milliters       St., South
                                (mL).                 Plainfield, NJ
                                                      07080.
ANDA 062483..................  Griseofulvin V        Valeant
                                (griseofulvin         Pharmaceuticals
                                microsize) Oral       North America,
                                Suspension, 125 mg/   LLC, 400 Somerset
                                5 mL.                 Corporate Blvd.,
                                                      Bridgewater, NJ
                                                      08807.
ANDA 063264..................  Amikacin Sulfate      Hospira, Inc., 275
                                Injection USP,        North Field Dr.,
                                Equivalent to (EQ)    Bldg. H1, Lake
                                250 mg base/mL.       Forest, IL 60045.
ANDA 072655..................  Amantadine            G&W Laboratories,
                                Hydrochloride (HCl)   Inc.
                                Syrup USP, 50 mg/5
                                mL.
ANDA 074176..................  Cimetidine HCl Oral   Do.
                                Solution, EQ 300 mg
                                base/5 mL.
ANDA 075366..................  Sotalol HCl Tablets   Upsher-Smith
                                USP 80 mg, 120 mg,    Laboratories, LLC,
                                160 mg, and 240 mg.   6701 Evenstad Dr.,
                                                      Maple Grove, MN
                                                      55369.
ANDA 075887..................  Fluvoxamine Maleate   Do.
                                Tablets, 25 mg, 50
                                mg, and 100 mg.
ANDA 076709..................  Fentanyl Extended-    Actavis
                                Release Film, 25      Laboratories UT,
                                micrograms (mcg)/     Inc., Subsidiary
                                hr, 50 mcg/hr, 75     of Teva
                                mcg/hr, 100 mcg/hr.   Pharmaceuticals
                                                      USA, Inc, 577
                                                      Chipeta Way, Salt
                                                      Lake City, UT
                                                      84108.
ANDA 076841..................  Mesalamine Enema, 4   G&W Laboratories,
                                grams (gm)/60 mL.     Inc.
ANDA 077062..................  Fentanyl Extended-    Mayne Pharma LLC,
                                Release Film, 25      1240 Sugg Parkway,
                                mcg/hr, 50 mcg/hr,    Greenville, NC
                                75 mcg/hr, and 100    27834.
                                mcg/hr.
ANDA 078426..................  Zolpidem Tartrate     Morton Grove
                                Tablets, 5 mg and     Pharmaceuticals
                                10 mg.                Inc.
ANDA 078653..................  Ranitidine HCl        Do.
                                Tablets USP, EQ 150
                                mg base.
ANDA 078701..................  Ranitidine HCl        Do.
                                Tablets USP, EQ 150
                                mg base and EQ 300
                                mg base.
ANDA 078884..................  Ranitidine HCl        Do.
                                Tablets USP, EQ 75
                                mg base.
ANDA 087811..................  Phrenilin             Bausch Health US,
                                (acetaminophen and    LLC.
                                butalbital)
                                Tablets, 325 mg/50
                                mg.
ANDA 088761..................  Prometh VC Plain      G&W Laboratories,
                                (promethazine HCl     Inc.
                                and phenylephrine
                                HCl) Syrup, 5 mg/
                                5mL, and 6.25 mg/5
                                mL.
ANDA 088762..................  Prometh w/            Do.
                                Dextromethorphan
                                (promethazine HCl
                                and
                                dextromethorphan
                                hydrobromide)
                                Syrup, 6.25 mg/5 mL
                                and 15 mg/5 mL.
ANDA 090786..................  Carbidopa,            Morton Grove
                                Entacapone, and       Pharmaceuticals
                                Levodopa Tablets,     Inc.
                                12.5 mg/200 mg/50
                                mg.
ANDA 091267..................  Donepezil HCl         Do.
                                Tablets, 5 mg and
                                10 mg.
ANDA 201947..................  Morphine Sulfate      VistaPharm, Inc.,
                                Oral Solution, 10     7265 Ulmerton Rd.,
                                mg/5 mL and 20 mg/5   Largo, FL 33771.
                                mL.
------------------------------------------------------------------------
Do = Ditto.

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
January 2, 2020. Approval of each entire application is withdrawn, 
including any strengths or products inadvertently missing from the 
table. Introduction or delivery for introduction into interstate 
commerce of products without approved new drug applications violates 
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331(a) and (d)). Drug products that are listed in the table that 
are in inventory on January 2, 2020 may continue to be dispensed until 
the inventories have been depleted or the drug products have reached 
their expiration dates or otherwise become violative, whichever occurs 
first.

    Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25946 Filed 11-29-19; 8:45 am]
 BILLING CODE 4164-01-P


