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Mylan's hypertension drug gets tentative approval
17 Jun 2008
Regulatory Affairs
Mylan' subsidiary, Mylan Pharmaceuticals, has received tentative approval from the US Food and Drug Administration (FDA) for its hypertension treatment, Irbesartan and Hydrochlorothiazide tablets.
The Pittsburg-based pharmaceutical company has said that Mylan Pharmaceuticals' Abbreviated New Drug Application for the drug, which is a generic version of Sanofi Aventis' Avalide tablets, has been granted tentative approval.
Mylan has 92 such applications waiting to be reviewed by the FDA.
According to IMS Health, Avalide made $288 million (£147 million) in sales in the US during the year ending March 31st 2008.
Earlier this month, Mylan announced that it is teaming up with Natco Pharma to market and distribute a generic version of Teva's Copaxone, a treatment for multiple sclerosis.
Robert Coury, Mylan vice-chairman and chief executive officer, said: "We plan to …leverage Mylan's considerable global expertise in regulatory applications to bring the therapeutic and economic benefits of this product to the widest possible patient-base."
