[Federal Register Volume 70, Number 166 (Monday, August 29, 2005)]
[Notices]
[Pages 51075-51076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0331]


Able Laboratories, Inc.; Withdrawal of Approval of Ten 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of ten abbreviated new drug applications (ANDAs) held by Able 
Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. Able 
Labs has initiated a class II recall of the products covered by these 
ANDAs. The company has requested that the applications be withdrawn and 
has waived its opportunity for a hearing.

DATES: Effective August 29, 2005.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: On May 25, 2005, Able Labs notified the 
agency that, because of improper laboratory practices and noncompliance 
with standard operating procedures, Able Labs was initiating a 
voluntary, class II recall of the products covered by the ANDAs listed 
in the table of this document. The company voluntarily requested 
withdrawal of approval of the ANDAs under Sec.  314.150(d) (21 CFR 
314.150(d)), and waived its opportunity for a hearing, provided under 
Sec.  314.150(a) and (b). The following ANDAs are affected by this 
action:

------------------------------------------------------------------------
              ANDA No.                               Drug
------------------------------------------------------------------------
40-395                               Diphenoxylate Hydrochloride (HCl)
                                      and Atropine Sulfate Tablets USP,
                                      2.5 milligrams (mg)/0.025 mg
------------------------------------------------------------------------
40-404                               Methylphenidate HCl Tablets USP, 5
                                      mg, 10 mg, and 20 mg
------------------------------------------------------------------------
40-407                               Prochlorperazine Suppositories USP,
                                      2.5 mg, 5 mg, and 25 mg
------------------------------------------------------------------------
40-452                               Acetaminophen and Codeine Phosphate
                                      Tablets USP, 300 mg/30 mg
------------------------------------------------------------------------
40-459                               Acetaminophen and Codeine Phosphate
                                      Tablets USP, 300 mg/60 mg
------------------------------------------------------------------------
71-780                               Clorazepate Dipotassium Tablets
                                      USP, 3.75 mg
------------------------------------------------------------------------
71-781                               Clorazepate Dipotassium Tablets
                                      USP, 7.5 mg
------------------------------------------------------------------------
71-782                               Clorazepate Dipotassium Tablets
                                      USP, 15 mg
------------------------------------------------------------------------

[[Page 51076]]

 
75-838                               Propoxyphene Napsylate and
                                      Acetaminophen Tablets USP, 100 mg/
                                      650 mg
------------------------------------------------------------------------
76-032                               Methylphenidate HCl Exended-Release
                                      Tablets USP, 20 mg
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research (21 CFR 5.105(a)), 
approval of the ANDAs listed in the table of this document, and all 
amendments and supplements thereto, is withdrawn, effective August 29, 
2005. Thereafter, distribution of the products in interstate commerce 
without approved applications is illegal and subject to regulatory 
action. Also, on the basis of the circumstances described in this 
document that led to the recall of the products and their subsequent 
removal from the market, the agency will remove the products from the 
agency's list of drug products with effective approvals, published 
under the title ``Approved Drug Products With Therapeutic Equivalence 
Evaluations.'' This document serves as notice of the removal of the 
products covered by the ANDAs listed in this document from the list of 
approved drug products. Distribution of these products in interstate 
commerce without approved applications is illegal and subject to 
regulatory action (see sections 505(a) and 301(d) of the act (21 U.S.C. 
355(a) and 331(d)).

    Dated: August 15, 2005.
Steven Galson,
Director, Center for Drug Evaluation and Research.
[FR Doc. 05-17151 Filed 8-26-05; 8:45 am]
BILLING CODE 4160-01-S