Saturday 14 June, 2008

Drug approvals: Teva got tentative approval for Valsartan tablets; Lupion launched Ramipril

Teva got tentative approval to market Valsartan Tablets
Teva Pharma announced that the USFDA has granted tentative approval for the Company's ANDA to market its generic version of Novartis' hypertension treatment Diovan(R) (Valsartan) Tablets, 40 mg, 80 mg, 160 mg and 320 mg. Final approval of this product is expected upon expiry of patent protection for the brand product in September 2012, as well as any periods of marketing exclusivity that may be awarded. The brand product had U.S. sales of approximately $1.5 billion for the twelve months ended March 30, 2008, according to IMS data.

Lupin launched Ramipril Capsule
Lupin Pharmaceuticals, Inc. announced today that the USFDA has granted final approval for the Company's ANDA for Ramipril capsules, 1.25 mg. 2.5 mg, 5 mg and 10 mg. Commercial shipments of the product have commenced. Lupin earlier was successful in invalidating product patent of innovator and subsequently USFDA gave 180 days exclusivity to Cobalt (first Para IV filer).

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