- Unresolved quality-control issues at Ranbaxy's Indian-based plants has led to withdrawal of approval and exclusivity for the generic version of Roche's Valcyte (valganciclovir), as well as tentative approval of generic Nexium (emeprazole)
- Ranbaxy was the first company to receive tentative approvals to launch copies of Valcyte and Nexium, with regulatory review processes dating back to 2008. One analyst said that the FDA's decision to yank support could cost Ranbaxy $250 million.
- These deals and others are at risk as the FDA maintains an import ban on all output from Ranbaxy's plant and intense scrutiny of the entire $15 billion Indian pharmaceutical industry. The agency also announced that it had approved two generic versions of Valcyte from Endo Laboratories and Dr. Reddy's Laboratories, according to an exclusive WSJ report.
Quality-control issues and recalls have been an unfortunate constant in pharma news out of India. It matters because there is widespread reliance on the Indian pharmaceutical industry, which is the largest supplier of generic medications to the U.S.
Ranbaxy spokespeople said that, while there were no "data integrity" issues, the compliance status of the manufacturing plants has put these two deals in jeopardy---and probably anything else the company has in the works.
The question for U.S. consumers now becomes: Just who will make a more affordable, generic version of Nexium? And when will it reach patients in America?