Generic valsartan approved in US

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Generic valsartan approved in US

Genéricos/Novedades | Posted 01/08/2014 0 Post your comment

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.

The drug is a generic of Novartis’s heart treatment drug, Diovan (valsartan), which is indicated for the treatment of high blood pressure and heart failure.

Ohm has received first-to-file FDA approval, giving the company 180 days of marketing exclusivity to manufacture and market generic valsartan in dosages of 40, 80, 160 and 320 mg tablets.

The originator brand, Diovan, has annual sales of US$2.19 billion, according to IMS Health.

The launch of the generic drug has been on hold since September 2012, when Diovan’s patent expired due to regulatory problems with the FDA [1]. However, with the Ohm site successfully passing an FDA inspection in October 2013, Ranbaxy may now be able to get back on track with some of its product launches, despite ongoing problems at its India-based facilities at Paonta Sahib, Dewas and Mohali [2].

Ranbaxy’s next big launch is expected to be a generic version of AstraZeneca’s blockbuster stomach-acid-relief drug, Nexium (esomeprazole), which had global sales in 2013 of US$3.9 billion, and was expected in May 2014.

References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Generics/News/Mylan-sues-FDA-over-Ranbaxy-s-generic-Diovan-exclusivity
2. GaBI Online - Generics and Biosimilars Initiative. Good news for Ranbaxy plant in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Generics/News/Good-news-for-Ranbaxy-plant-in-US

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Source: Ranbaxy