Ranbaxy fails to reverse FDA decision over Valcyte and Nexium

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Ranbaxy fails to reverse FDA decision over Valcyte and Nexium

Generics/News | Posted 20/03/2015 0 Post your comment

Indian generics company Ranbaxy has yet again failed in its bid to become the first company in the US to sell generic versions of the AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir). Launching the first generic copies of the drugs would have given Ranbaxy six months of exclusivity on the market.

In November 2014, Ranbaxy had sued the US Food and Drug Administration (FDA) for reversing an original approval to sell its generic versions of Nexium and Valcyte. Ranbaxy, arguing that the retraction wrongly punished the company for deficiencies found at two of its production facilities in India, had also requested the court to issue a temporary restraining order asking the regulator not to give approvals for other companies to sell their own generics.

Ranbaxy has not only failed to gain approval to export its two generics to the US, but Judge Beryl Howell of the United States District Court for the District of Colombia also blocked Ranbaxy's request for a temporary restraining order to halt Teva Pharmaceutical Industries Ltd, Endo International Plc and Dr Reddy's Laboratories Ltd from launching copies of the two drugs.

Dr Reddy’s Laboratories, determined not to follow suit and lose out on FDA approval for its generic version of Nexium, was recently considering switching manufacturing to a new facility [1]. Dr Reddy’s made esomeprazole at a facility in India’s Srikakulam district, but FDA had raised concerns about the facility’s suitability following an inspection of the site.

India-based Sun Pharmaceutical announced in April 2014 that it was acquiring Ranbaxy in an all-stock deal worth US$3.2 billion [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Dr Reddy’s could move manufacturing site with view to FDA approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Generics/News/Dr-Reddy-s-could-move-manufacturing-site-with-view-to-FDA-approval
2. GaBI Online - Generics and Biosimilars Initiative. Sun Pharma to acquire Ranbaxy creating 5th largest generics firm [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Pharma-News/Sun-Pharma-to-acquire-Ranbaxy-creating-5th-largest-generics-firm

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