Sunday, 23 July 2017

Generic Azilect tablets launched by Mylan

05 June 2017 | News

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of Parkinson's disease.

Mylan announced the U.S. launch of Rasagiline Tablets, 0.5 mg and 1 mg, a generic version of the reference listed drug, Teva's Azilect Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of Parkinson's disease.

Rasagiline Tablets, 0.5 mg and 1 mg, had U.S. sales of approximately $343 million for the 12 months ending March 31, 2017. Currently, Mylan has 234 ANDAs pending FDA approval representing approximately $104 billion in annual brand sales.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. The company offers a growing portfolio of approximately 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50 per cent of people being treated for HIV/AIDS in the developing world depend.

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