Strides Pharma receives FDA OK for 2 generics
Strides Pharma has obtained the Food and Drug Administration’s approval for two generics.
Strides’ subsidiary, Strides Pharma Global, Singapore, has received approval from the FDA for Sodium Sulphate, Potassium Sulphate and Magnesium Sulphate Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces, which is the generic of Braintree’s Suprep Bowel Prep Kit Oral Solution. 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 market value of $143 million, per IQVIA. It will be manufactured at the company’s facility in Bengaluru.
[Read more: Strides Pharma obtains FDA clearance for generic Actigal]
Sodium Sulphate, Potassium Sulphate and Magnesium Sulphate Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces 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.
Strides’ subsidiary, Strides Pharma Global, Singapore, also has received the FDA’s approval for Levetiracetam Oral Solution, 100 mg/ml, which is the generic of UCB’s Keppra Oral Solution. It is used in the treatment of seizures.
The Levetiracetam Oral Solution has a market value of $55 million, per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.
[Read more: Strides obtains FDA nod for generic ibuprofen oral suspension]