Approvals Withdrawn for Ten Able Labs ANDAs
Approvals for Ten Able Labs ANDAs Withdrawn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the request of the beleaguered Able Laboratories (Cranbury, NJ) the US Food and Drug Administration (Rockville, MD) has withdrawn 10 of the company’s abbreviated new drug approvals.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According to FDA’s Aug. 29 Federal Register notice, the withdrawn drugs are diphenoxylate hydrochloride and atropine sulfate tablets USP, methylphenidate HCL tablets USP, prochlorperazine suppositories USP, acetaminophen and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
Clinical Supply Planning in Europe - Balancing Cost, Flexibility and Time
December 19th 2024The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.
