viewMylan Inc.

Mylan NV shares rocket thanks to FDA approval

The FDA has approved its generic abbreviated drug versions of Teva Pharmaceutical Industries Ltd's Copaxone

MS can lead to life in a wheelchair

Shares in pharma group Mylan NV (NASDAQ:MYL) shot up 17.59%  in New York on the back of Food and Drug Administration (FDA) approval news.

The latter has approved its generic abbreviated drug versions of Teva Pharmaceutical Industries Ltd's Copaxone - a drug for people with relapsing forms of the debilitating disease multiple sclerosis.

"The FDA approvals of Mylan's Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL as AP-rated, substitutable generics for Copaxone 20 mg/mL and 40 mg/mL, respectively, mark another significant milestone for our company, reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market, and further our commitment to providing access to high quality medicines," said Mylan's chief executive Heather Bresch.

Copaxone is the most prescribed MS treatment for relapsing forms of MS in the USA with brand sales for the 20 mg/mL dose of around US$700 million and for the 40 mg/mL dose of around $3.64 billion for the 12 months to end July this year.

Teva's shares fell 9% in premarket trading.

Mylan shares surged 17.09% to US$38.09 each, before easing back a bit to US$37.80.

Quick facts: Mylan Inc.

Price: 16.32 USD

Market: NASDAQ
Market Cap: $8.44 billion

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