Strides Receives USFDA Approval for Cyproheptadine HCL Tablets

Strides Shasun Limited’s wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received approval for Cyproheptadine Hydrochloride Tablets USP, 4 mg from the United States Food and Drug Administration (USFDA). Cyproheptadine Hydrochloride tablets are a generic version of Periactin Tablets of Merck & Co. Inc.

According to IQVIA data, the US market for Cyproheptadine Hydrochloride Tablets USP, 4 mg is approximately USD 20 million. 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 74 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 46 ANDAs have been approved as of date and 28 are pending approval.