U.S. pulls approval for Ranbaxy copies of AstraZeneca, Roche drugs
By Zeba Siddiqui MUMBAI (Reuters) – The U.S. Food and Drug Administration 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'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. …
