Document ID: FDA-2020-N-0601-0001
Agency: fda
Document Type: Notice
Title: Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
Posted Date: 2020-03-09T04:00Z

[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Page 13661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04691]

[[Page 13661]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0601]

Mylan Institutional LLC et al.; Withdrawal of Approval of 16 
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 16 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 8, 2020.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) (21 CFR 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 040471.................  Promethazine          Mylan Institutional
                               Hydrochloride (HCl)   LLC, 4901 Hiawatha
                               Injection, 25         Dr., Rockford, IL
                               milligrams (mg)/      61103.
                               milliliters (mL).
ANDA 060286.................  Penicillin G          Pfizer, Inc., 235
                               Procaine Injection,   East 42nd St., New
                               300,000 units/mL      York, NY 10017.
                               and 600,000 units/
                               mL.
ANDA 065247.................  Cefazolin Sodium for  Hospira, Inc., 275
                               Injection,            North Field Dr.,
                               Equivalent to (EQ)    Bldg. H1, Lake
                               10 grams base/vial.   Forest, IL 60045.
ANDA 065488.................  Azithromycin Oral     Lupin
                               Suspension, EQ 100    Pharmaceuticals,
                               mg base/5 mL; EQ      Inc., 111 South
                               200 mg base/5 mL.     Calvert St.,
                                                     Harborplace Tower,
                                                     21st Floor,
                                                     Baltimore, MD
                                                     21202.
ANDA 076185.................  Dimethyl Sulfoxide    Mylan Institutional
                               Intravesical          LLC.
                               Solution, 50%.
ANDA 076428.................  Milrinone Lactate     Do.
                               Injection, EQ 1 mg
                               base/mL.
ANDA 076488.................  Mesna Injection, 100  Do.
                               mg/mL.
ANDA 078410.................  Topiramate Tablets,   Lupin
                               25 mg, 50 mg, 100     Pharmaceuticals,
                               mg, and 200 mg.       Inc.
ANDA 078957.................  Stavudine Capsules,   Hetero USA, Inc.,
                               15 mg, 20 mg, 30      1035 Centennial
                               mg, and 40 mg.        Ave., Piscataway,
                                                     NJ 08854.
ANDA 090441.................  Imipramine HCl        Lupin
                               Tablets, 10 mg, 25    Pharmaceuticals,
                               mg, and 50 mg.        Inc.
ANDA 200563.................  Ciprofloxacin Oral    Do.
                               Suspension, 250 mg/
                               5 mL and 500 mg/5
                               mL.
ANDA 205657.................  Chlorpheniramine      Mayne Pharma Inc.,
                               Maleate,              1240 Sugg Pkwy.,
                               Hydrocodone           Greenville, NC
                               Bitartrate, and       27834.
                               Pseudoephedrine HCl
                               Solution, 4 mg/5
                               mL; 5 mg/5 mL; and
                               60 mg/5 mL.
ANDA 205658.................  Hydrocodone           Do.
                               Bitartrate and
                               Pseudoephedrine HCl
                               Oral Solution, 5 mg/
                               5 mL; and 60 mg/5
                               mL.
ANDA 200624.................  Metformin HCl, and    Lupin
                               Repaglinide           Pharmaceuticals,
                               Tablets, 500 mg/1     Inc.
                               mg; 500 mg/2 mg.
ANDA 202384.................  Omeprazole Delayed-   Do.
                               Release Capsules,
                               40 mg.
ANDA 202532.................  Clarithromycin        Do.
                               Extended-Release
                               Tablets, 500 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of April 
8, 2020. Approval of each entire application is withdrawn, including 
any strengths and dosage forms 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 April 8, 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: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04691 Filed 3-6-20; 8:45 am]
 BILLING CODE 4164-01-P