Document ID: FDA-2021-N-0033-0002
Agency: fda
Document Type: Notice
Title: Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications; 
Correction
Posted Date: 2021-05-20T04:00Z

[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Page 27440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10588]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0033]

Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval 
of Seven 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 of March 5, 2021. The document 
announced the withdrawal of approval of seven abbreviated new drug 
applications (ANDAs) from multiple applicants as of April 5, 2021. The 
document indicated that FDA was withdrawing approval of the following 
five ANDAs, after receiving a withdrawal request from Neopharma, Inc., 
211 College Road East, Suite 101, Princeton, NJ 08540: ANDA 078383, 
Pioglitazone Hydrochloride (HCl) Tablets, Equivalent to (EQ) 15 
milligrams (mg) base, EQ 30 mg base, and EQ 45 mg base; ANDA 078953, 
Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100 
mg/5 mL (20 mg/mL); ANDA 079049, Alendronate Sodium Tablets, EQ 5 mg 
base, EQ 10 mg base, EQ 35 mg base, and EQ 70 mg base; ANDA 090732, 
Anastrozole Tablets, 1 mg; and ANDA 203161, Irbesartan Tablets, 75 mg, 
150 mg, and 300 mg. Before FDA withdrew the approval of these ANDAs, 
Neopharma, Inc., informed FDA that it did not want the approval of the 
ANDAs withdrawn. Because Neopharma, Inc., timely requested that 
approval of these ANDAs not be withdrawn, the approval of ANDAs 078383, 
078953, 079049, 090732, and 203161 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, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, March 5, 
2021 (86 FR 12950), appearing on page 12950 in FR Doc. 2021-04520, the 
following corrections are made on pages 12950 and 12951 in the table:
    The entries for ANDAs 078383, 078953, 079049, 090732, and 203161 
are removed.

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10588 Filed 5-19-21; 8:45 am]
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