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Natco Pharma at record high; partner Mylan files ANDA

"Marketing partner in the USA, Mylan Inc has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/ml) and has been accepted by the US Food and Drug Administration (US FDA)," said the company in its filing.

September 01, 2014 / 17:04 IST
 
 
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Moneycontrol Bureau

Investors lapped up shares of Natco Pharma on Monday after its marketing partner, Mylan Inc filed ANDA for generic Copaxone (to treat patients with relapsing forms of multiple sclerosis). The stock gained as much as 5 percent to touch a record high of Rs 1,262.55.

"Marketing partner in the USA, Mylan Inc has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/ml) and has been accepted by the US Food and Drug Administration (USFDA)," said the company in its filing.

Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.

In North America, Copaxone is marketed by Teva Neuroscience, Inc, which is a subsidiary of Teva. Copaxone 40 mg/ml had US sales of approximately USD 411.5 million for the 12 months ending June 30, 2014, according to IMS Health.

At 10:39 hours IST, the stock was quoting at Rs 1,249.90, up Rs 47.45, or 3.95 percent on the BSE.

Posted by Sunil Shankar Matkar

first published: Sep 1, 2014 11:06 am

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