Sun Pharmaceutical Industries has received US FDA approval for its 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. It expects Ximino extended-release capsules to be available for patients during the fourth quarter of 2015.
Ximino extended-release capsules consist of extended release formulation of minocycline HCl capsules 45 mg, 90 mg and 135 mg and are indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.