Mylan Unveils Generic Temodar Capsules

Mylan N.V. MYL disclosed the 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, in the United States. According to the company, it received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this product.

Mylan said Temozolomide Capsules were indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. The company quoted IMS Health to say that Temozolomide Capsules had sales of about $176.5 million in the 12 months ending May 31 in the United States.

Currently, the company has 246 ANDAs pending before the FDA for approval. The company quoted IMS Health to say that it represented $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.

The stock traded 0.60 percent higher at the time of writing.