USFDA approves Zydus Cadila drugs for brain tumour, hypertension

Zydus Cadila's Temozolomide is a chemotherapy drug used in the management of brain tumours
Drug firm Zydus Cadila on Tuesday said it has received approval from the US health regulator to market Temozolomide capsules, used in the treatment of brain tumour, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) to market Temozolomide capsules in strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, Zydus Cadila said in a statement.

Temozolomide is a chemotherapy drug used in the management of brain tumours. As per IMS sales data, sale of Temozolomide in the US market is estimated to be around USD 100.4 million.

The Ahmedabad-based company has also received final approval from the USFDA to market Nadolol tablets in the US market.

Nadolol is used in management of hypertension and angina pectoris (chest pain). As per IMS sales data, sales of Nadolol tablets in the US is estimated at USD 109.8 million.

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 from the USFDA. IT has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003- 04.


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