Sun Pharmaceutical Industries said it has received approval from the US health regulator for its new drug application for acne treatment medicine--XiminoTM extended-release capsules, reported PTI.
The US Food and Drug Administration (USFDA) has approved the company's supplemental New Drug Application (sNDA) for XiminoTM (Minocycline HCl) extended-release capsules in strengths of 45 mg, 90 mg and 135 mg, Sun Pharma said in a statement.
XiminoTM 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 XiminoTM extended-release capsules to be available for patients during the fourth quarter of 2015," the Mumbai-based company said.
Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical firm.
The company's consolidated revenues for 12 months ended March 2015 stood at around USD 4.5 billion, of which US contributed USD 2.2 billion.