Document ID: FDA-2022-N-0995-0001
Agency: fda
Document Type: Notice
Title: Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams
Posted Date: 2022-07-27T04:00Z

[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45109-45110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16077]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0995]

Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an 
Abbreviated New Drug Application for Chloramphenicol Capsules, 250 
Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
approval of abbreviated new drug application (ANDA) 062247 for 
chloramphenicol capsules, 250 milligrams (mg), held by Ivax 
Pharmaceuticals, Inc. (Ivax). Ivax requested withdrawal of this 
application and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of July 27, 2022.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: On April 28, 1980, FDA approved ANDA 062247 
for chloramphenicol capsules, 250 mg, an antibiotic indicated to treat 
only serious infections for which less potentially dangerous drugs are 
ineffective or contraindicated. CHLOROMYCETIN (chloramphenicol) 
Capsules, 250 mg (ANDA 060591), was the basis of submission for Ivax's 
ANDA 062247 for chloramphenicol capsules, 250 mg. In a Federal Register 
notice dated July 13, 2012 (77 FR 41412), FDA determined under 21 CFR 
314.161 that CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg (ANDA 
060591), was withdrawn for safety reasons and that additional 
nonclinical and possibly clinical studies of safety and efficacy would 
be necessary before CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, 
could be considered for reintroduction to the market. The holders of 
approved applications for chloramphenicol capsules, 250 mg, had ceased 
marketing of the drug products before July 13, 2012.
    On March 29, 2013, Ivax requested that FDA withdraw approval of 
ANDA 062247 for chloramphenicol capsules, 250 mg. On June 17, 2021, 
Ivax requested that FDA withdraw approval of ANDA 062247 for 
chloramphenicol capsules, 250 mg, specifically under Sec.  314.150(d) 
(21 CFR 314.150(d)) and waived its opportunity for a hearing. For the 
reasons discussed above, and pursuant to the application holder's 
request under 314.150(d), approval of ANDA 062247 for chloramphenicol 
capsules, 250 mg, and all amendments and supplements thereto, is 
withdrawn under Sec.  314.150(d). Distribution of chloramphenicol 
capsules, 250 mg, into interstate commerce without an approved 
application is illegal and subject to regulatory action (see sections 
505(a) and 301(d) of the Federal Food,

[[Page 45110]]

Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d))).

    Dated: July 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16077 Filed 7-26-22; 8:45 am]
BILLING CODE 4164-01-P