FDAnews Drug Daily Bulletin

FDA WITHDRAWS ANDA APPROVALS FOR ABLE LABS

Sept. 7, 2005
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At Able Laboratories' request, the FDA has withdrawn approval of 10 abbreviated new drug applications (ANDAs) for generic drugs.

The FDA's withdrawal follows Able's voluntary recall in May of the 10 drugs because of improper laboratory practices and noncompliance with standard operating procedures.

"The company has requested that the applications be withdrawn and has waived its opportunity for a hearing," according to the FDA notice.

The revoked ANDAs include generic versions of Novartis Pharmaceuticals' attention-deficit/hyperactivity disorder drug Ritalin (methylphenidate HCl); GlaxoSmithKline's antinausea drug Compazine (prochlorperazine); Ovation Pharmaceuticals' anti-anxiety drug Tranxene (clorazepate dipotassium); Xanodyne Pharmaceutical's pain treatment Darvocet-N (propoxyphene napsylate/acetaminophen); Pfizer's severe diarrhea drug Lomotil (diphenoxylate HCl/atropine sulfate) and versions of Tylenol with codeine (acetaminophen/codeine phosphate).

Able's manufacturing troubles surfaced in May after an internal review revealed a slew of drug manufacturing and development problems. After the review, the generic drugmaker recalled its entire product line and halted manufacturing operations.