FDA warning letter says Empower's compounded GLP-1 changes are pretextual
The agency told the Houston outsourcing facility that its B-vitamin-added tirzepatide and semaglutide too closely copy Novo Nordisk and Eli Lilly products.
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By Daniel Okafor · Regulatory Correspondent
Sep 22 18:35 ETSource: Houston Chronicle
The wire
- 01The FDA letter, dated Sept. 18 and released Tuesday, says the volume of GLP-1s Empower compounds suggests differences from approved drugs are pretextual, and cites quality problems from a November inspection.
- 02It is Empower's fifth warning letter since 2017 and signals how the agency may treat 503B facilities adding vitamins or altering dosage forms to justify compounding copies of approved incretins.
- 03CEO Shaun Noorian says many issues are already remediated and the company will work with the FDA; the agency did not immediately comment, and no enforcement action has been announced.
From the source
Read at houstonchronicle.comFDA takes issue with Empower Pharmacy's GLP-1 production in new warning letter
Empower Pharmacy CEO Shaun Noorian is reflected in the doors of the company's FDA-registered outsourcing facility on Thursday, Sept. 29, 2016, in Houston.
