US FDA approves Sun Pharma's Ximino

20 August 2015

Indian drugmaker Sun Pharmaceutical Industries (SUN: BO) yesterday announced that the US Food and Drug Administration has approved its supplemental New Drug Application (sNDA) for Ximino(minocycline HCl) extended-release capsules. Sun Pharma’s shares rose 2.24%, to trade at 948.00 rupees on the news.

Ximinoextended-release capsules are indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. This approval further strengthens the company’s branded dermatology portfolio in the USA. Sun expects the product to be available for patients in the USA during the fourth quarter of 2015.

After its acquisition of Ranbaxy, the company has firmed up plans to make dermatology its biggest revenue segment and reports indicate it expects about 40% of US sales to come from dermatology by fiscal year 2018.

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