The U.S. Food and Drug Administration (FDA) has revoked a tentative approval for India's Ranbaxy Laboratories to make a cheap copy of AstraZeneca's heartburn drug Nexium, after its Indian plants were banned over quality control issues.
The FDA has also stripped Ranbaxy of tentative approval and six-month exclusivity for a copy of Roche Holding's antiviral Valcyte, a fresh blow to the Indian company that has been hit by a raft of regulatory bans over poor production quality.
The U.S. regulator has banned output from all Ranbaxy's India-based plants under a wider scrutiny of the country's $15 billion pharmaceutical industry, which is the largest supplier of generic medicines to the United States.
Ranbaxy was the first company to receive tentative approvals to launch copies of the two drugs as long ago as 2008, making it eligible to exclusively market the medicines for six months - a huge revenue generating opportunity.
The launch of Nexium and Valcyte generics had been awaiting final approval from the FDA. That was delayed as Ranbaxy struggled to resolve quality issues.
Ranbaxy said on Thursday the FDA had informed it that the regulator's original decisions granting tentative approval were "in error because of the compliance status of the facilities."