Ranbaxy Sues FDA Over Revoked Generic Approvals

Nov. 18, 2014

Ranbaxy Laboratories has sued the U.S. FDA for revoking approvals granted to launch generic copies of AstraZeneca's Nexium and Roche's Valcyte.

The FDA pulled the tentative approvals earlier this month due to ongoing quality control issues at Ranbaxy's Indian plants. Dr Reddy's was then granted final approval from the FDA to make a generic version of the antiviral, Valcyte. 

In the lawsuit, filed in the District of Columbia, Ranbaxy said the FDA's action violated constitutional rights, exceeded the agency's statutory authority, and was "arbitrary, capricious, and otherwise contrary to law."

Ranbaxy has also requested the court to restrain FDA from approving any other generic versions of Valcyte or Nexium until its six-month exclusive periods on the launch of the drugs has ended.

Read the ET press release