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Mylan introduces lamivudine tablets, 100 mg in US market
Pittsburgh | Saturday, January 17, 2015, 13:00 Hrs  [IST]

Mylan Inc., a global pharmaceutical company, has launched lamivudine tablets, 100 mg in US market, which is the generic version of GlaxoSmithKline's Epivir-HBV.

Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation.

Lamivudine tablets, 100 mg, had US sales of approximately $18.1 million for the 12 months ending September 30, 2014, according to IMS Health.

Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1 billion in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.

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