Strides Pharma Ibuprofen Oral Suspension gets USFDA okay

Bengaluru: Strides Pharma Science Limited has recently announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC) from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Infants' Advil  Concentrated Drops, 50 mg/1.25 mL (40 mg/mL) (OTC), of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

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

The Product approval further strengthens Strides Ibuprofen franchise for the US markets. Strides was granted 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).

Strides will have a 180 days of Competitive Generic Therapy (CGT) exclusivity for the product, under section 505(j)(5)(B)(v) of the FD&C Act.

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The US OTC market for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) is approximately ~US$ 41 Mn.

The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

The company has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 251 ANDAs have been approved and 23 are pending approval. The company currently has ~60 commercialized products in the US and has set a target to launch ~ 20 new products every year from the combined portfolio.

Strides Pharma Science Singapore arm had earlier received USFDA approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL.

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