Strides Pharma Science (Strides) today announced that its step] down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Sodium Sulphate, Potassium Sulphate and Magnesium Sulphate Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces (Product) from the United States Food & Drug Administration (USFDA).
The Product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Suprep Bowel Prep Kit Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces of Braintree Laboratories Inc. (Braintree).
The approval bolsters the Company's portfolio of products in bowel preparation that spans both prescription and over the counter offerings. The Product has a marketsize of ~US$143 Mn per IQVIA.
The Product will be manufactured at the companyfs facility in Bengaluru.
The Product belongs to a group of medicines prescribed to those who are required to undergo a colon cleanse prior to a colonoscopy. The kit is available in a carton containing two 6 ounce bottles of the liquid and a mixing container. |