Approvals Withdrawn for Ten Able Labs ANDAs

Approvals for Ten Able Labs ANDAs Withdrawn

At the request of the beleaguered Able Laboratories (Cranbury, NJ) the US Food and Drug Administration (Rockville, MD) has withdrawn 10 of the company’s abbreviated new drug approvals. The drugs were voluntarily recalled in May after an internal investigation turned up improper laboratory practices, including failure to ensure that all drug product distributed had the safety, identity, quality, and purity that they are represented to possess; and failure to reject drug products that failed to meet established standards and specifications.

According to FDA’s Aug. 29 Federal Register notice, the withdrawn drugs are diphenoxylate hydrochloride and atropine sulfate tablets USP, methylphenidate HCL tablets USP, prochlorperazine suppositories USP, acetaminophen and codeine phosphate, acetaminophen and codeine phosphate, clorazepate dipotassium tablets, clorazepate dipotassium tablets, clorazepate dipotassium tablets, propoxyphene napsylate and acetaminophen tablets, and methylphenidate HCL extended-release Tablets USP.

–George Koroneos