Strides Pharma gets FDA approval for Ibuprofen oral suspension

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Strides Pharma Science Limited said that its stepdown fully-owned subsidiary — Pte. Limited, Singapore, has secured approval from the US Food and Drug Administration (FDA) for Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).

The pain drug product from Strides Pharma is the generic of GlaxoSmithKline Consumer Healthcare Holdings (US)’s Infants’ Advil Concentrated Drops, 50 mg/1.25 mL (40 mg/mL) (OTC).

According to Strides Pharma Science, the approval of its product further bolsters its Ibuprofen franchise for the American markets.

Strides Pharma gets FDA approval for Ibuprofen oral suspension

Strides Pharma gets approval for oral suspension. Photo courtesy of Joby.joe/Wikipedia.org.

was given a Competitive Generic Therapy (CGT) designation by the for its ANDA. Its product is the “first approved applicant” for Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).

The company will have a 180 days of Competitive Generic Therapy (CGT) exclusivity for Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC), under section 505(j)(5)(B)(v) of the FD&C Act.

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