New Delhi: Strides Shasun said its wholly-owned subsidiary has received approval from the US health regulator for Cyproheptadine Hydrochloride tablets, used to relieve allergy symptoms.
In a BSE filing, it said Strides Pharma Global Pte. has received approval from the United States Food and Drug Administration (USFDA) for Cyproheptadine Hydrochloride tablets USP, 4mg.
The approved product is a generic version of Periactin tablets of Merck & Co. Inc.
Strides said the product will be manufactured at its oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in the US.
Citing IQVIA data, the company said the US market for Cyproheptadine Hydrochloride tablets USP, 4 mg is approximately USD 20 million.
Cyproheptadine Hydrochloride tablets is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, sneezing, hives, and itching.