US regulator revokes tentative approvals for two Ranbaxy generics
The US FDA has determined that the Indian drug manufacturer Ranbaxy forfeit its 180 days exclusivity for esomeprazole magnesium delayed release capsules used to treat stomach and aesophagus problems.
Ranbaxy says it is 'disappointed' with the result and is 'pursuing all available legal options to preserve its rights'.
In November 2014, the US regulator revoked its tentative approvals for Ranbaxy's generic anti viral drug valganciclovir hydrochloride and esomeprazole magnesium delayed release capsules 20mg and 40mg.
While the FDA said Ranbaxy's abbreviated new drug application (ANDA) did not have any data integrity issues, it 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'.