Document ID: FDA-2011-N-0411-0003
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications: Bristol-Myers Squibb Co., et al.; Correction
Posted Date: 2011-12-22T05:00Z

[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79701-79702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32822]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0411]

Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New 
Drug Applications and 97 Abbreviated New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of June 8, 2011 (76 FR 33310). 
The document announced the withdrawal of approval of 70 new drug 
applications (NDAs) and 97 abbreviated new drug applications (ANDAs) 
from multiple applicants, effective July 8, 2011. The document 
indicated that FDA was withdrawing approval of the following three 
ANDAs after receiving a request from the ANDA holder, A.H. Robins Co., 
c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-
8299: ANDA 086661, DONNATAL (phenobarbital, hyoscyamine sulfate, 
atropine sulfate, scopolamine (HBr)) Elixir; ANDA 086676, DONNATAL 
(phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine 
(HBr)) Tablets; and ANDA 086677, DONNATAL (phenobarbital, hyoscyamine 
sulfate, atropine sulfate, scopolamine (HBr)) Capsules. Before 
withdrawal of these ANDAs became effective, PBM Pharmaceuticals, Inc., 
acquired the rights to the ANDAs and informed FDA that it did not want 
them withdrawn. Because the basis for withdrawal would have been a 
request from the ANDA holder and the request was timely withdrawn, the 
approval of ANDAs 086661, 086676, and 086677 is still in effect.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, (301) 
796-3601.

SUPPLEMENTARY INFORMATION: In FR Doc. 2011-14164 appearing on page 
33310, in the Federal Register of Wednesday, June 8, 2011, the 
following correction is made:
    On page 33313, in Table 1, the entries for ANDAs 086661, 086676, 
and 086677 are removed.

[[Page 79702]]

    Dated: December 16, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-32822 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P