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  • on 19.11.2014
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Ranbaxy Files Complaint Against FDA Over Revocation of Tentative Approvals For ANDAs For Esomeprazole Magnesium Delayed-Release Capsules And… [Global Data Point]

Nov19

Ranbaxy Files Complaint Against FDA Over Revocation of Tentative Approvals For ANDAs For Esomeprazole Magnesium Delayed-Release Capsules And Valganciclovir Hydrochloride Tablets
FDA has said 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. 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.

(c) 2014 GlobalData Provided by SyndiGate Media Inc. (Syndigate.info).

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