Sun Pharmaceutical's subsidiary has received the final US FDA approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Temodar, Temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg.
Temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg are therapeutic equivalents of Merck Sharp & Dohme Corporation’s Temodar capsules. These capsules have annual sales of approximately US$ 400 million in the US.
Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and for adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
Temodar is the registered trademark of Merck Sharp & Dohme Corp.