The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical’s supplemental new drug application (sNDA) for Ximino (minocycline HCl) extended-release capsules 45 mg, 90 mg and 135 mg.
Ximino extended-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 US. Sun Pharma expects Ximino extended-release capsules to be available for patients during the fourth quarter of 2015.