Mylan debuts first generic Diovan HCT and Antivert in USA

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Mylan debuts first generic Diovan HCT and Antivert in USA

Generics/News | Posted 12/10/2012 0 Post your comment

Mylan is first off the mark once again with its latest generics launch. Mylan announced on 21 September 2012 that its subsidiary Mylan Pharmaceuticals has received final approval from FDA for its Abbreviated New Drug Application (ANDA) for valsartan/hydrochlorothiazide tablets USP.

Eighth first-to-file launch this year
Valsartan/hydrochlorothiazide tablets are the generic version of Novartis’ Diovan HCT tablets, which are indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals [1]. Mylan has received FDA approval for its generic version in the following dosages: 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg.

The originator brand had US sales of approximately US$1.6 billion for the 12 months ending 30 June 2012, according to IMS Health. Mylan is shipping the product immediately.

Mylan CEO, Ms Heather Bresch commented that ‘Mylan’s launch of the first generic valsartan/hydrochlorothiazide tablets USP represents our eighth first-to-file launch this year, demonstrating our continued leadership in bringing new generic drug products to the market. Through this launch, we are proud to continue contributing to the increased healthcare savings experienced by patients, governments and payors in the US supported by the generics availability of an important, widely prescribed product such as this one.’

Generic Antivert
Mylan has received final approval from FDA for its ANDA for meclizine hydrochloride tablets USP in dosages of 12.5 mg, 25 mg and 50 mg. This product is the generic version of Pfizer’s Antivert, which is indicated for the management of nausea and vomiting, and dizziness associated with motion sickness.

Antivert tablets had US sales of approximately US$53.5 million for the 12 months ending 30 June 2012, according to IMS Health. This product will also be available immediately.

Currently, Mylan has 168 ANDAs pending FDA approval representing US$77.8 billion in annual sales, according to IMS Health. Thirty-three of these pending ANDAs are potential first-to-file opportunities, representing Euros 16 billion in annual brand sales, for the 12 months ending 30 June 2012.

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Source: Mylan