Strides Pharma Science Limited (Strides) today announced that its step‐down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for Triamcinolone Acetonide Ointment USP, 0.05% from the United States Food & Drug Administration (USFDA).

While it was amongst the few Competitive Generic Therapy (CGT) designated products for Strides, another generic company received approval prior to our approval. Consequently, the final approval for Strides will be effective 30 May 2020 when the company will launch the product. According to IQVIA MAT data, the US market for Triamcinolone Acetonide Ointment USP, 0.05% is approximately US$ 20 Mn. The product will be manufactured at the company’s Oral dosage facility at Bangalore and will be marketed by Strides Pharma Inc. in the US market.

The company has 102 cumulative ANDA filings with USFDA of which 69 ANDAs have been approved and 33 are pending approval.  

Triamcinolone Acetonide Ointment is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis.