Ranbaxy loses 6 months exclusivity for generic antiviral drug

USFDA said that its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs

Drug firm Ranbaxy Laboratories on Thursday said the US health regulator has revoked its tentative approvals for its generic anti-viral drug and stomach and esophagus problems treatment tablets. “As a consequence, in FDA's view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets USP, 450 mg,” Ranbaxy Laboratories said in a filing to BSE. The communication from US Food and Drug Administration (USFDA) said that Ranbaxy's ANDAs of concern did not have any data integrity issues.

However 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." FDA has rescinded the previously granted tentative approvals for Ranbaxy’s ANDAs for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride tablets USP, 450 mg, Ranbaxy Laboratories said.

“Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights,” the company said.