[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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of April 8, 2020.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, [email protected].
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.
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Application No. Drug Applicant
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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.
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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