Zydus receives final approvals from USFDA for skin ointment, heart medicine

Drug maker Zydus Cadila Saturday said it has received final approval from the US health regulator to market Betamethasone Dipropionate Cream that is used to treat a variety of skin conditions.

The group also received a final nod for Amlodipine and Atorvastatin Tablets USP that is administered for heart and cholesterol-related cases.

"Zydus Cadila has received the final approval from the USFDA to market Betamethasone Dipropionate Cream USP (US RLD DIPROLENE AF), 0.05 per cent. It will be manufactured at the group's Topical manufacturing facility at Ahmedabad," Zydus said in a regulatory filing.

This medication is a strong corticosteroid and is used to treat a variety of skin conditions (like eczema, dermatitis, allergies, rash), it added.

The group also received a final approval for Amlodipine and Atorvastatin Tablets USP (US RLD - Caduet) in various strengths and will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, the statement said.

"This combination product contains two active ingredients - amlodipine and atorvastatin. Amlodipine reduces blood pressure and the workload on the heart...It is used to lower blood pressure and to treat angina (chest pain)," it explained.

Atorvastatin, on the other hand, is used in combination with diet and exercise to treat high cholesterol. It works by blocking an enzyme that is needed to make cholesterol in the body.

According to the statement, the group now has 245 approvals and has so far, filed over 330 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY2003-04.