FDA Rescinds Tentative Approval for Ranbaxy ANDAs

The US Food and Drug Administration has rescinded Ranbaxy Laboratories Limited’s previously granted tentative approvals for the company’s abbreviated new drug applications (ANDAs) for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg, and for valganciclovir hydrochloride tablets USP, 450 mg. Esomeprazole magnesium is the generic version of AstraZeneca’s gastrointestinal drug, Nexium, and valganciclovir hydrochloride is the generic version of Roche’s antiviral drug, Valcyte.

In a statement, Ranbaxy said that FDA said 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. 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.

In the statement, the company said: “Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights.” The company added that Ranbaxy’s ANDAs of concern did not have any data-integrity issues.

Ranbaxy, which is being acquired by Sun Pharmaceutical Industries in a deal announced in April 2014, has had quality control issues at its manufacturing facilities, which included an FDA import alert issued earlier this year for active pharmaceutical ingredients manufactured at Ranbaxy’s facility in Toansa, India.

Source: Ranbaxy

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