The Hyderabad based NATCO Pharma Limited is pleased to announce the acceptance for review by the US Food and Drug Administration, of the ANDA (Abbreviated New Drug Application) filed by its partner – the Pittsburgh based Mylan, Inc. for Glatiramer Acetate injection (20 rng/ ml). This is the generic version of Teva’s Copaxone – a product indicated for the treatment of multiple sclerosis.
NATCO Pharma Ltd. had during 2008, entered into a licensing and supply pact with Mylan, Inc., which grants Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in US and other major markets.
This acceptance represents a significant achievement to bring hard to make generic version to the market. The Company awaits successful completion of review and any possible litigation.
The product sales globally are expected to be nearly 3 billon US dollars in 2009.
(Source: Company press release)
The share moved up 20% on 15 September 2009 on the back of this news.
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