Generic / cGMPs

FDA Revokes Ranbaxy's Approval to Make AstraZeneca and Roche Generics

Source: Reuters

Nov 06, 2014

The U.S. FDA has revoked a tentative approval for India's Ranbaxy Laboratories to make inexpensive copies of AstraZeneca's heartburn drug Nexium, as well as stripped Ranbaxy of tentative approval and six-month exclusivity for a copy of Roche Holding's antiviral Valcyte.

The decisions were made based on ongoing quality control issues at Ranbaxy's Indian plants.

Nexium lost patent protection in the U.S. in May, while Valcyte is projected to lose patent protection in 2015.

In 2008, Ranbaxy was the first company to receive tentative approvals to launch copies of the two drugs, but have been awaiting final FDA approval as the plants struggled with compliance issues.

Read the Reuter's press release