US FDA approval for Hep B and osteoporosis generics

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

US FDA approval for Hep B and osteoporosis generics

Generics/News | Posted 04/09/2015 0 Post your comment

Indian generics maker Aurobindo Pharma (Aurobindo) has received US Food and Drug Administration (FDA) approval for two more generics from its portfolio, bringing its total abbreviated new drug application (ANDA) approvals to 210 (182 final and 28 tentative).

The company announced on 27 August 2015 that it had received final approval from FDA for its generic entecavir tablets in dosages of 0.5 and 1.0 mg (ANDA 206217).

The generic drug is bioequivalent and therapeutically equivalent to Bristol-Myers Squibb’s Baraclude (entecavir). Entecavir tablets are indicated for treatment of chronic hepatitis B (Hep B) virus infection of the liver. The product has an estimated market size of US$294 million for the 12 months ending June 2015 according to IMS.

Aurobindo also announced on 29 August 2015 that the company had received final approval from FDA for its generic raloxifene tablets in dosages of 60 mg (ANDA 204310).

The generic drug is bioequivalent and therapeutically equivalent to Eli Lilly’s Evista (raloxifene). Raloxifene tablets are indicated for treatment and prevention of osteoporosis in postmenopausal women. The product has an estimated market size of US$404 million for the 12 months ending June 2015 according to IMS.

Aurobindo is one of the top 10 companies in India in terms of revenue. The company exports to over 125 countries across the globe with more than 70% of its revenues derived out of international operations.

In 2014, Aurobindo purchased the generic operations of Actavis in Belgium, France, Germany, Italy, The Netherlands, Portugal and Spain, making it one of the leading Indian pharmaceutical companies in Europe [1].

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Aurobindo to acquire seven generics businesses from Actavis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Pharma-News/Aurobindo-to-acquire-seven-generics-businesses-from-Actavis

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Aurobindo