MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.
Temozolomide capsules are used for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy. It also serves as a maintenance treatment and for adult patients with refractory anaplastic astrocytomas that have experienced disease progression on a drug regimen containing nitrosourea and procarbazine, according to the company.
Temozolomide capsules are therapeutic equivalents of Merck Sharp & Dohme's Temodar capsules. The capsules have annual sales of approximately $400 million.