GMP deficiencies cited by FDA inspectors in a Form 483 for one of Baxter’s injectable drug manufacturing facilities were the reason why the agency did not approve a Cadence NDA by its user fee action goal date.
Baxter, contract manufacturer for Cadence’s intravenous acetaminophen drug candidate, told FDAnews that it plans to fully address the agency’s concerns, but would not provide details of the agency’s findings, which were received Feb. 5 at the Cleveland, Miss., facility.
A few days after the inspection, Cadence received a complete response letter from the FDA for the IV acetaminophen. In an investor conference call, Cadence CEO Ted Schroeder said Baxter’s GMP deficiencies were the reason the FDA did not approve the NDA.
Schroeder also declined to provide details on the deficiencies, noting that Cadence was only informed of FDA observations on Baxter’s acetaminophen manufacturing. He says he believes the inspection was a routine facility inspection and doesn’t know whether the FDA will need to reinspect. The Baxter plant manufactures other large-volume parenterals, including Baxter’s multisource products, Schroeder added. — April Hollis
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