FDA approves first generic esomeprazole

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FDA approves first generic esomeprazole

Genéricos/Novedades | Posted 30/01/2015 0 Post your comment

Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. The drug is indicated to treat gastroesophageal reflux disease (GERD) in adults and children aged one year and older.

Ivax Pharmaceuticals, a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 mg capsules.

India-based generics maker Ranbaxy Laboratories (Ranbaxy) was due to launch a generic version of esomeprazole back in May 2014, when the key patent on Nexium expired in the US. However, due to import bans at its Dewas, Mohali, Paonta Sahib and Toansa sites for good manufacturing procedure violations [1], the company was unable to cash in on its 180-days of marketing exclusivity. FDA then went so far as to revoke Ranbaxy’s tentative approval for its generic esomeprazole, ‘because of the compliance status of the facilities referenced in the abbreviated new drug applications at the time the tentative approvals were granted’ [2].

AstraZeneca’s blockbuster acid-reflux drug Nexium had annual sales of approximately US$6 billion in the US, according to IMS data as of November 2014.

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues Ranbaxy with Form 483 for violations at Toansa plant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 30]. Available from: www.gabionline.net/Generics/News/FDA-issues-Ranbaxy-with-Form-483-for-violations-at-Toansa-plant
2. GaBI Online - Generics and Biosimilars Initiative. FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 30]. Available from: www.gabionline.net/Generics/News/FDA-revokes-Ranbaxy-s-esomeprazole-and-valganciclovir-ANDAs

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Source: FDA, Teva