Judge Rules in Favor of FDA in Ranbaxy Drug Approval Suit

March 17, 2015

U.S. District Judge Beryl Howell ruled that the FDA is within its right to revoke approval of Ranbaxy's generic Nexium (esomeprazole) and Valcyte (valganciclovir).

As reported by BioPharmaDive, after the FDA revoked the two ANDAs from Ranbaxy, six years after granting them, it subsequently granted approvals for the same two drugs to three other companies, including Endo, Dr. Reddy's and Teva. Ranbaxy responded last November by suing FDA for revoking the tentative approvals.

Although Judge Howell chastised the FDA for taking so long to revoke the approvals, the FDA claimed Ranbaxy was unresponsive to all attempts to further the investigation of cGMP vioations at manufacturing facilities, thus delaying the eventual ANDA revocation.