Mylan N.V. , a global pharmaceutical company, announced the US launch of temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a generic version of Merck's Temodar.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumours known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, had US sales of approximately $176.5 million for the 12 months ending May 31, 2016, according to IMS Health.
Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.