Mylan debuts first generic Diovan HCT and Antivert copy in USA

US generic drugmaker Mylan (Nasdaq: MYL) last Friday received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for valsartan and hydrochlorothiazide tablets USP, 80/12.5mg, 160/12.5mg, 160/25 mg, 320/12.5mg and 320/25mg, a generic version of Swiss drug major Novartis' (NOVN: VX)blockbuster blood pressure drug Diovan HCT.…

Mylan chief executive Heather Bresch commented: "Mylan's launch of the first generic valsartan and hydrochlorothiazide tablets USP represents our eighth first-to-file launch this year, demonstrating our continued leadership in bringing new generic products to the market. Through this launch, we are proud to continue contributing to the increased health care savings experienced by patients, governments and payers in the USA supported by the generic availability of an important, widely prescribed product such as this one."

Valsartan HCT in the specified doses had US sales of about $1.6 billion for the 12 months ending June 30, 2012, according to IMS Health quoted by Mylan, which said it is shipping this product immediately. The company says it will have 180 days marketing exclusivity.