[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30962-30963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10924]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0766]
Hospira, 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of June 21, 2022.
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 040140............... Diphenhydramine Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection, 50 Building H1-3S, Lake
milligrams (mg)/ Forest, IL 60045.
milliliters (mL).
ANDA 040578............... Benzphetamine HCl ScinoPharm Taiwan,
Tablets, 50 mg. Ltd., 909 N Ford
Ave., Fullerton, CA
92832.
ANDA 065267............... Cefprozil Tablets, Bionpharma Inc., 600
250 mg, and 500 mg. Alexander Rd., Suite
2-4B, Princeton, NJ
08540.
ANDA 065284............... Cefprozil Oral Do.
Suspension, 125 mg/5
mL and 250 mg/5 mL.
[[Page 30963]]
ANDA 065301............... Cefadroxil Tablets, Do.
Equivalent to (EQ) 1
gram (g) base.
ANDA 065307............... Cefadroxil Oral Do.
Suspension, EQ 250
mg base/5 mL and EQ
500 mg base/5 mL.
ANDA 065309............... Cefadroxil Capsules, Do.
EQ 500 mg base.
ANDA 065326............... Cephalexin Oral Do.
Suspension, EQ 125
mg base/5 mL and EQ
250 mg base/5 mL.
ANDA 076720............... Morphine Sulfate Nesher
Extended Release Pharmaceuticals
Tablets, 30 mg, and (USA) LLC., 13910
60 mg. Saint Charles Rock
Rd., Bridgeton, MO
63044.
ANDA 076733............... Morphine Sulfate Do.
Extended Release
Tablets, 15 mg.
ANDA 077855............... Morphine Sulfate Do.
Extended Release
Tablets, 100 mg and
200 mg.
ANDA 080225............... Potassium Chloride Fresenius Kabi USA,
Injection, 2 LLC, Three Corporate
milliequivalent Dr., Lake Zurich, IL
(mEq)/mL and 3 mEq/ 60047.
mL.
ANDA 202393............... Diclofenac Sodium TWi Pharmaceuticals,
Topical Solution, Inc., 536 Vanguard
1.5%. Way, Brea, CA 92821.
ANDA 203581............... Glyburide Tablets, Sunny Pharmtech Inc.,
1.25 mg, 2.5 mg, and 175 SW 166th Ave.,
5 mg. Pembroke Pines, FL
33027.
ANDA 204137............... Omeprazole and Sodium Unicorn
Bicarbonate Pharmaceuticals, 5
Capsules, 20 mg; 1.1 Links Circle,
g. Durham, NC 27707.
ANDA 206588............... Dextroamphetamine Nesher
Sulfate Tablets, 5 Pharmaceuticals
mg, and 10 mg. (USA) LLC.
ANDA 208263............... Doxycycline Hyclate Do.
Capsules, EQ 50 mg
base and EQ 100 mg
base.
ANDA 209111............... Dextroamphetamine Do.
Sulfate Extended
Release Capsules, 5
mg, 10 mg, and 15 mg.
ANDA 210079............... Oxycodone and Do.
Acetaminophen
Tablets, 325 mg; 2.5
mg, 325 mg; 5 mg,
325 mg; 7.5 mg, 325
mg; 10 mg.
ANDA 210080............... Dextroamphetamine Do.
Saccharate,
Amphetamine
Aspartate,
Dextroamphetamine
Sulfate, and
Amphetamine Sulfate
Extended Release
Capsules, 1.25 mg;
1.25 mg; 1.25 mg;
1.25 mg, 2.5 mg; 2.5
mg; 2.5 mg; 2.5 mg,
3.75 mg; 3.75 mg;
3.75 mg; 3.75 mg, 5
mg; 5 mg; 5 mg; 5
mg, 6.25 mg; 6.25
mg; 6.25 mg; 6.25
mg, 7.5 mg; 7.5 mg;
7.5 mg; 7.5 mg.
ANDA 211543............... Butalbital, Do.
Acetaminophen, and
Caffeine Tablets,
325 mg; 50 mg; 40 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 June
21, 2022. 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 June 21, 2022, 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: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10924 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P