Strides Shasun gets USFDA go-ahead for anti-allergy drug
New Delhi: Strides Shasun said it has received approval from the US health regulator for promethazine hydrochloride tablets used to treat allergy symptoms, nausea and vomiting related to certain conditions.
The product will be manufactured at the company's Bengaluru facility and marketed by Strides Pharma Inc in the US market.
In a BSE filing, Strides Shasun said it has received approval from the United States Food and Drug Administration (USFDA) for promethazine hydrochloride tablets USP, 12.5mg, 25 mg and and 50 mg.
Citing IMS sales data, Strides Shasun said the US market for the approved product is approximately USD 17 million.
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