Lannett Company, Inc. announced that its wholly owned subsidiary, Kremers Urban Pharmaceuticals Inc. (KU), has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for temozolomide capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug Temodar capsules of Merck & Co.
According to IMS, total US sales in 2015 of temozolomide capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg at Average Wholesale Price (AWP) were approximately $206 million.
"Temozolomide is an important chemotherapy agent used to treat a certain type of brain tumor," said Arthur Bedrosian, chief executive officer of Lannett. "This product represents the first approval received from our recently completed acquisition of KU. We expect to commence marketing shortly."