Sun Pharma Drops Appeal Against FDA

Sun Pharmaceuticals has quietly dropped an appeal of a lawsuit challenging the FDA’s authority to revoke the tentative approval of two generics made by its Ranbaxy subsidiary.

The case, Ranbaxy Laboratories, Ltd. et al v. Burwell et al, stems from the FDA’s decision to reverse the tentative approvals of knock offs of AstraZeneca’s heartburn drug Nexium (esomeprazole magnesium) and Hoffman-La Roche’s AIDS drug Valycte (valganciclovir HCl), due to GMP problems at a Ranbaxy facility in India.

Ranbaxy sued the FDA in November 2014, arguing the agency only has the authority to refuse final approval of an ANDA.

On March 3, the U.S. District Court for the District of Columbia upheld the FDA’s decision, but criticized the agency’s tentative approval of the drugs, citing inadequate internal communications and a rushed, poorly thought-out approval process. Sun appealed the ruling on March 6, just weeks before its acquisition by Sun was completed.

David Rosen, an attorney at Foley & Lardner, says that until an application is finally approved, the FDA has a lot of discretion to withdraw a tentative approval it believes was granted in error, even though such action is not expressly permitted by the FD&C Act.

The withdrawal of the appeal was noted in a regulatory filing earlier this month with the Bombay Stock Exchange. No explanation was offered there or in a stipulated agreement of dismissal filed by the drugmaker and the FDA last week in the U.S. Court of Appeals for the District of Columbia Circuit.

Neither party could be reached for comment by press time. — Jonathon Shacat