Zydus Cadila gets FDA tentative approval for acne treatment generic

Zydus Cadila has secured tentative approval from the US Food and Drug Administration (FDA) for marketing Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%.

A generic of Galderma’s Epiduo Forte, Adapalene and Benzoyl Peroxide Gel 0.3%/2.5% is intended for the treatment of acne.

The combination of adapalene and benzoyl peroxide works by destroying the bacteria that cause acne and by helping in the cleaning of the skin pores.

Zydus Cadila said that it will manufacture the acne gel at its topical plant in Ahmedabad, India.

The Indian pharma company now has 323 approvals and has to date filed more than 400 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.