Drugs

Order Wells Pharma Indomethacin Off Market: Petition

An 11/7 Wiley Rein petition submitted on behalf of a client asks FDA to order the complete and immediate withdrawal of the Wells Pharma compounded 100 mg indomethacin suppository. The petition also calls on the agency to require Wells to cease manufacturing and distribution of the suppository until it performs the necessary pharmaceutical development, non-clinical, and clinical studies, and obtains FDA approval for this new strength through an NDA, including payment of all PDUFA fees.

“This product is marketed on a factually incorrect basis to circumvent established drug approval pathways,” the petition says. “More alarmingly, its formulation creates novel, uncharacterized, and highly immunogenic impurities that pose a significant and direct risk to public health.”

Other requests in the petition are to:

order Wells to demonstrate full compliance with the U.S. Pharmacopeia monograph for indomethacin suppositories;
classify the Wells product as a misbranded drug; and
issue a determination that the change in strength from the approved 50 mg to the compounded 100 mg, combined with the novel formulation, raises significant questions of safety and effectiveness.

The petition says Wells has claimed that higher doses are needed since FDA-approved alternatives contain problematic excipients. But, it says, approved alternatives such as Zydus Pharmaceuticals’ 50 mg suppository do not contain the excipients, making Wells’ claim false.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome