Friday, 06 December 2019

Zydus gets approval to market chest pain drug and corticosteroid cream

22 November 2019 | News

Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets and Desonide Cream

Zydus Cadila has received the final approval from the USFDA to market Isosorbide Dinitrate Tablets USP (US RLD – Isordil Tablet) in the strengths of 5 mg, 10 mg, 20 mg, 30 mg and 40 mg.

The drug is used to prevent attacks of chest pain (angina). It dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump. It will be manufactured at the group’s formulations manufacturing facility at Baddi.

The group also received the final approval for Desonide Cream (US RLD – Desonide Cream), 0.05%. The drug is a mild corticosteroid, used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash) to reduce swelling, itching and redness that can occur in these types of conditions. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad.

The group now has 278 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

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