Strides obtains FDA nod for generic ibuprofen oral suspension

Strides’ subsidiary, Strides Pharma Global, has received approval for ibuprofen oral suspension, 50 mg/1.25 ml (40 mg/ml) (OTC), from the Food and Drug Administration.

The product is the generic of GSK’s Consumer Healthcare’s Infants’ Advil Concentrated Drops, 50 mg/1.25 ml (40 mg/ml) (OTC).

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Strides was granted a Competitive Generic Therapy designation for its ANDA and is the “first approved applicant” for ibuprofen oral suspension, 50 mg/1.25 ml (40 mg/ml) (OTC). The company will have 180 days of CGT exclusivity for the product, according to Strides.

The OTC market for ibuprofen oral suspension is roughly $41 million, the company said.

The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the United States.

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Ibuprofen is a nonsteroidal anti-inflammatory drug used to relieve pain from various conditions, such as headache, dental pain, menstrual cramps, muscle aches or arthritis. It also is used to reduce fever and to relieve minor aches and pain due to the common cold or flu.