Sunday, 24 March 2019

Strides gets USFDA nod to market laxative drug in US

26 December 2018 | News

Strides Pharma Global, Singapore, has received approval for Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP in the strengths of 236 grams/2.97 grams/6.74 grams/5.86 grams/22.74 grams/4 Liter from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a filing to BSE.

Drug firm Strides Pharma Science's subsidiary has received approval from the US health regulator to market laxative Polyethylene Glycol 3350 and Electrolytes for Oral Solution.

Strides Pharma Global, Singapore, has received approval for Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP in the strengths of 236 grams/2.97 grams/6.74 grams/5.86 grams/22.74 grams/4 Liter from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a filing to BSE.

The approved product is a generic version of GoLYTELY of Braintree Laboratories.

With the current approval, Strides now offers a complete range of PEG 3350 Laxatives for the US markets comprising of three approved products addressing a combined prescription and OTC opportunity of USD 400 million as per IMS and IRi data, the company said.

The product will be manufactured at Strides' facility in Bengaluru and will be marketed by Strides Pharma in the US market.

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