 "US FDA revokes Ranbaxy's approvals for antiviral and heartburn drugs")
The US Food and Drug Administration (US FDA) has revoked Ranbaxy’s six months exclusivity for generic version of Roche Holding AG's antiviral Valcyte and the tentative approval to make a generic version of AstraZeneca's heartburn drug Nexium granted to the pharma major.
The approvals were revoked citing the compliance status of Ranbaxy production facilities. According to the statement by Ranbaxy, US FDA also added that, “Its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted." However, FDA has not raised any data integrity issues related to the filing for the two drugs by Ranbaxy, the statement said.
Ranbaxy was the first company to receive tentative approvals to launch generic versions 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 approvals were revoked citing the compliance status of Ranbaxy production facilities. According to the statement by Ranbaxy, US FDA also added that, “Its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted." However, FDA has not raised any data integrity issues related to the filing for the two drugs by Ranbaxy, the statement said.
Ranbaxy was the first company to receive tentative approvals to launch generic versions 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.