US FDA Approves Topical Acne Gel Developed By Zydus Lifesciences


The Zydus Lifesciences said, it has received the final approval from the Food and Drug Administration (FDA) of the United States for marketing the Adapalene and Benzoyl Peroxide topical gel in the United States.

The topical gel has been a generic version of the drug Epiduo Forte listed in the US reference and the Adapalene and Benzoyl Peroxide topical gel also had a market size of 195 million dollars.

The gel, which is a combination of the Adapalene (a retinoid) and Benzoyl Peroxide (which is an antibiotic and skin-peeling agent, has been used for the purpose of decreasing the number and seriousness of the acne pimples. The Adapalene mainly works by affecting the growth of the cells and decreasing the swelling and inflammation and Benzoyl Peroxide works by decreasing the amount of the bacteria causing acne causing the skin to dry and peel off.

The gel is going to be manufactured at the topical facility of the company, which is located in Ahmedabad, India. The company is now having 315 approvals and has also filed for more than 420 ANDAs since the commencement of the process of filing in the financial year 2003-2004 so far.

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