Mylan introduces generic paraplatin injection

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 for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents.

Mylan also received final approval for Carboplatin Injection, 150 mg/15 ml, 450 mg/45 ml, 600 mg/60 ml, in multi-dose vials, and intends to launch these presentations subsequently.

Carboplatin Injection, 50 mg/5 ml, 150 mg/15 ml, 450 mg/45 ml, and 600 mg/60 ml had U.S. sales of approximately $30.4 million for the 12 months ending March 31, 2014, according to IMS Health. This launch bolsters Mylan’s growing portfolio of cancer treatment and supportive care products.

Currently, Mylan has 299 ANDAs pending FDA approval representing $105.2 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.