Strides Shasun has announced that its wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received approval for cyproheptadine hydrochloride tablets USP, 4 mg from the United States Food & Drug Administration (US FDA).
Cyproheptadine hydrochloride tablets is a generic version of Periactin tablets of Merck & Co. Inc.
Cyproheptadine hydrochloride tablets is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, sneezing, hives, and itching.
According to IQVIA data, the US market for cyproheptadine hydrochloride tablets USP, 4 mg is approximately US$ 20 million. The product will be manufactured at the company’s oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 74 cumulative ANDA filings with US FDA of which 46 ANDAs have been approved as of date and 28 are pending approval.