Drug firm Strides Pharma Science on Saturday said its subsidiary has received approval from the US health regulator to market ibuprofen oral suspension, used to treat pain and fever, in the US market.
Singapore-based Strides Pharma Global Pte, a step-down wholly owned subsidiary of the company, has received approval from the US Food and Drug Administration (FDA) for its product.
Strides Pharma Science said in a statement that the company’s product is clinically equivalent to GlaxoSmithKline Consumer Healthcare Holdings’ Advil Concentrated Drops.
The approval of the product further strengthens the company’s ibuprofen franchise for the US markets, it added.
Strides said it was given a Competitive Generic Therapy (CGT) designation for its ANDA and is “the first approved applicant” for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).
The drug firm will have 180 days of Competitive Generic Therapy (CGT) exclusivity for the product.
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions, such as headache, toothache, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and relieve minor aches and pains caused by the common cold or flu.
The US OTC market for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) is approximately $41 million.
The product will be manufactured at Stride’s plant in Bengaluru and will be marketed in the US market by Strides Pharma Inc.
The company said it now has 274 cumulative ANDA filings with the US FDA (including the recently acquired portfolio from Endo on Chestnut Ridge), of which 251 ANDA have been approved and 23 are pending approval.
The pharmaceutical firm currently has 60 commercial products in the US and aims to launch 20 new products each year from the combined portfolio.