[Federal Register: August 29, 2005 (Volume 70, Number 166)]
[Notices]
[Page 51075-51076]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au05-63]
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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 The company has requested that the applications be withdrawn and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:
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ANDA No. Drug
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40-395 Diphenoxylate Hydrochloride (HCl)
and Atropine Sulfate Tablets USP,
2.5 milligrams (mg)/0.025 mg
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40-404 Methylphenidate HCl Tablets USP, 5
mg, 10 mg, and 20 mg
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40-407 Prochlorperazine Suppositories USP,
2.5 mg, 5 mg, and 25 mg
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40-452 Acetaminophen and Codeine Phosphate
Tablets USP, 300 mg/30 mg
------------------------------------------------------------------------
40-459 Acetaminophen and Codeine Phosphate
Tablets USP, 300 mg/60 mg
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71-780 Clorazepate Dipotassium Tablets
USP, 3.75 mg
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71-781 Clorazepate Dipotassium Tablets
USP, 7.5 mg
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71-782 Clorazepate Dipotassium Tablets
USP, 15 mg
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[[Page 51076]]
75-838 Propoxyphene Napsylate and
Acetaminophen Tablets USP, 100 mg/
650 mg
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76-032 Methylphenidate HCl Exended-Release
Tablets USP, 20 mg
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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