Document ID: FDA-2022-N-0766-0002
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications; Correction
Posted Date: 2022-07-29T04:00Z

[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Notices]
[Page 45778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16281]

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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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on May 20, 2022. The document 
announced the withdrawal of approval (as of June 21, 2022) of 21 
abbreviated new drug applications (ANDAs) from multiple applicants. The 
document indicated that FDA was withdrawing approval of the following 
ANDAs after receiving withdrawal requests from Bionpharma Inc., 600 
Alexander Rd., Suite 2-4B, Princeton, NJ 08540: ANDA 065301, Cefadroxil 
Tablets, Equivalent to (EQ) 1 gram (g) base; ANDA 065307, Cefadroxil 
Oral Suspension, EQ 250 milligrams (mg) base/5 milliliters (mL) and EQ 
500 mg base/5 mL; ANDA 065309, Cefadroxil Capsules, EQ 500 mg base; 
ANDA 065326, Cephalexin Oral Suspension, EQ 125 mg base/5 mL and EQ 250 
mg base/5 mL; from Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke 
Pines, FL 33027: ANDA 203581, Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 
mg; and from Unicorn Pharmaceuticals, 5 Links Circle, Durham, NC, 
27707: ANDA 204137, Omeprazole and Sodium Bicarbonate Capsules, 20 mg; 
1.1 g. Before FDA withdrew the approval of these ANDAs, Bionpharma 
Inc., Sunny Pharmtech Inc., and Unicorn Pharmaceuticals informed FDA 
that they did not want the approval of the ANDAs withdrawn. Because 
Bionpharma Inc. timely requested that approval of ANDAs 065301, 065307, 
065309, and 065326 not be withdrawn, the approvals are still in effect. 
Because Sunny Pharmtech Inc. timely requested that ANDA 203581 not be 
withdrawn, the approval is still in effect. Because Unicorn 
Pharmaceuticals timely requested that ANDA 204137 not be withdrawn, the 
approval is still in effect.

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: In the Federal Register of Friday, May 20, 
2022 (87 FR 30962), in FR Doc. 2022-10924, the following correction is 
made:
    On page 30963, in the table, the entries for ANDAs 065301, 065307, 
065309, 065326, 203581, and 204137 are removed.

    Dated: July 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16281 Filed 7-28-22; 8:45 am]
BILLING CODE 4164-01-P