Mylan NV shares rocket thanks to FDA approval

At the NSE it zoomed 19.99 per cent to touch its upper circuit limit of Rs 952.40

At the NSE it zoomed 19.99 per cent to touch its upper circuit limit of Rs 952.40

Natco Pharma, a leading pharma company engaged in developing, manufacturing and marketing finished dosage formulations (FDF) has informed in its filing that its marketing partner Mylan has received USFDA (US Food and Drug Administration) approval for Glatiramer Acetate injection in strengths of 40 mg/mL and 20 mg/mL.

Shares of the Natco Pharma surged 20% and got locked in the upper circuit on Wednesday after its USA marketing partner received FDA approval for Natco Pharma's generic Glatiramer Acetate.

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Mylan's announcement came shortly after the FDA unveiled a series of new measures created to speed up the time it takes generic versions of complex drugs to reach the market.

In a press release, Mylan said it will begin shipping 20 mg and 40 mg doses of its generic version of Teva Pharma's (TEVA) popular Copaxone drug immediately.

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Mylan N.V. also notes that the FDA approval letter points out that it was one of the first companies to submit an Abbreviated New Drug Application with a Paragraph IV certification.

On Wednesday, Teva's US -listed shares sank 14 percent to $16.17, while Mylan's shares rose $5.96 to $38.48. "/" Class="local_link" >(NASDAQ:MYL) shot up 17.59% in NY on the back of Food and Drug Administration (FDA) approval news. Mylan's market share is expected to reach as high as 40% with Wells Fargo predicting sales at about $172 million per quarter that will result in Teva's full year earnings to drop $3 per share by next year. For Teva, however, it meant generic competition 9 to 12 months ahead of previous Wall Street expectations.

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Last month, Teva said it was looking to team up with other drugmakers to fund some of its development pipeline as it struggles with debt and expiring patents. The moves came as the agency attempts to deal with the rising cost of drugs in the U.S.

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