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Mylan introduces rovatriptan succinate tablets 2.5 mg in US market

Hertfordshire, England Saturday, May 14, 2016, 12:00 Hrs  [IST]

Mylan N.V., a global pharmaceutical company, announced the US launch of frovatriptan succinate tablets 2.5 mg, a generic version of Endo's Frova tablets. Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used to treat acute migraine headaches in adults.

Frovatriptan succinate tablets 2.5 mg had US sales of approximately $88.3 million for the 12 months ending March 31, 2016, according to IMS Health.

Currently, Mylan has 260 ANDAs pending FDA approval representing $109.1 billion in annual brand sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $37.5 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

 
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