Mylan N.V., a global pharmaceutical company, announced the US launch of rosuvastatin calcium tablets, 5 mg, 10 mg, 20 mg and 40 mg, which is a generic version of AstraZeneca's Crestor.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Rosuvastatin calcium tablets are used in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults.
Rosuvastatin calcium tablets, 5 mg, 10 mg, 20 mg and 40 mg, had US sales of approximately $6.7 billion for the 12 months ending May 31, 2016, according to IMS Health.
Currently, Mylan has 245 ANDAs pending FDA approval representing $101.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $30.8 in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.