India's Ranbaxy sues FDA for yanking Nexium, Valcyte generics approval
- The FDA pulled tentative approvals that it had previously granted to Ranbaxy for the generic development of Nexium (for heartburn) and Valcyte (an antiviral) due to manufacturing-quality concerns.
- Ranbaxy is suing in response, asserting that the FDA is "violating constitutional rights exceeding its statutory authority."
- The FDA followed up its rescission of Ranbaxy's Nexium and Valcyte approvals by granting two other companies, Dr. Reddy's Labs and Endo International, the right to create generic Valcyte. Ranbaxy has requested that the FDA not be allowed to grant the approvals to other companies.
Ranbaxy, based in Mumbai, India, has been hit with one sanction after another in the last year. To put it lightly, that's been bad for business.
This is particularly bad timing for Ranbaxy as it prepares to be acquired by Sun Pharmaceutical Industries (also in India) for $3.2 billion. The cost of losing these approvals is estimated to be approximately $200 million for the first six months alone.
At the time, the FDA is not commenting on the case.