FDA Declines to Review Teva's Citizen Petition for Copaxone

Source: FDANews.com. The FDA has declined to review a citizen petition submitted by the neuroscience division of Teva Pharma (TEVA) asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment until certain conditions are met. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. In addition, the FDA didn’t address or take action on Teva’s requests in the petition, the company says in a statement.

Momenta Pharma's partner, the Sandoz division of Novartis (NVS), filed an abbreviated new drug application (ANDA) for a generic version (M356) of Teva Pharma's (TEVA) multiple sclerosis drug Copaxone (glatiramer acetate injection) ($2.3B in sales for 2008) on 12/27/07 which was accepted for review by the FDA on 7/11/08.

The Generic Drug Division of the FDA does not issue decision date deadlines. Sandoz is currently involved in litigation with TEVA over M356 as a generic equivalent which was filed with a Paragraph IV Certification. The P4 notification officially informed Teva that the M356 ANDA contains a certification of the patents listed for Copaxone in the FDA's Orange Book are either invalid or not infringed.

In September 2008, Teva filed a Citizen’s Petition, requesting that the FDA not approve an ANDA or a 505(b) (2) application for generic Copaxone, without clinical studies due to the complexity of Copaxone, and the limitations of methods for analyzing a complex product such as Copaxone. A product cannot be launched until after the 30 month litigation stay (Feb. 2011) -- can then launch at risk if ANDA approved.

BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section

---

Add this page to your favorite Social Bookmarking websites