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

Press Trust of India  |  New Delhi 

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

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

"has received the final approval from the USFDA to market Dipropionate USP (US RLD DIPROLENE AF), 0.05 per cent. It will be manufactured at the group's Topical 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 and Atorvastatin Tablets USP (US RLD - Caduet) in various strengths and will be manufactured at the group's formulations at SEZ, Ahmedabad, the statement said.

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

Atorvastatin, on the other hand, is used in combination with diet and exercise to treat 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.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Sat, January 12 2019. 12:50 IST
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