Lannett Files Lawsuit Against FDA for Yanking Erroneously Approved ANDA

July 7, 2016

FDA has been hit with its second suit in as many days, this time for approving and then rescinding an ANDA.

Generic drugmaker Lannett Company contends in its suit that its constitutionally protected property rights were violated when the FDA withdrew its approval for a cancer drug without affording the company a hearing on the matter.

The agency granted Lannett an ANDA for the chemotherapy drug temozolomide in March, but revoked it two months later, contending that the approval was “mistakenly granted” as a result of “review and endorsement process errors.”

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