Cadila Healthcare Ltd (Zydus Cadila) has received final approval from the USFDA to market Temozolomide capsules in strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg.
Temozolomide capsule is a chemotherapy drug used in the management of brain tumours. Its sales is estimated at $100.4 million per annum in the US, the company said here on Tuesday.
The Zydus Group also received final approval from the USFDA to market Nadolol tablets USP, 20 mg, 40 mg, and 80 mg. Nadolol is used in the management of hypertension (high blood pressure) and angina pectoris (chest pain). Its sales is estimated at $109.8 million per annum.
Both the drugs will be manufactured at the Group’s formulations manufacturing facility at the Pharma SEZ, Ahmedabad.
The Group now has more than 130 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.