January 31: Strides Shasun Limited has announced that it’s wholly owned subsidiary Strides Pharma Global Pte. Limited has received approval for Nystatin and Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food & Drug Administration (USFDA). This is the first topical approval received from the new semi solids block at the flagship plant in Bangalore. The topical product line is an important new addition to Strides’ portfolio of oral solid dosage products and the Bangalore manufacturing plant supports several current and future topical submissions for the US Market. The product received approval within ten months under the GDUFA regime. According to IMS data, the US market for Nystatin and Triamcinolone Acetonide Ointment USP, 0.1% is approximately USD 18 Million. The product will be marketed by Strides Pharma Inc. in the US Market.
Nystatin and Triamcinolone Acetonide Ointment is used in treatment of fungal skin infections. The product contains nystatin, an anti-fungal drug that works by stopping the growth of fungus. It also contains triamcinolone, an anti-inflammatory corticosteroid that works by reducing swelling, itching, and redness.