Strides Pharma secures USFDA approval for generic Ibuprofen oral suspension

INDIA – Strides Pharma has announced that its Singapore-based subsidiary had received approval from the US Food and Drug Administration for generic Ibuprofen oral suspension, which is used to relieve pain from a variety of conditions.

The US Food and Drug Administration (FDA) approved the company’s step-down wholly-owned subsidiary Strides Pharma Global, Singapore, for Ibuprofen oral suspension in the strength of 100 mg/5 ml, the company said in a statement.

According to the company, the product is bioequivalent and therapeutically equivalent to McNeil Consumer Healthcare’s (McNeil) Reference Listed Drug (RLD) Motrin oral suspension, 100 mg/5 ml.

Strides Pharma Inc will market the product in the United States after it is manufactured at the company’s Bengaluru facility.

Citing IQVIA MAT March 2022 data, the company said the US market for Ibuprofen oral suspension 100 mg/5 ml is approximately US$66 million.

Strides said it has 274 abbreviated new drug application (ANDA) filings with the US FDA, with 250 approved and 24 pending approval.

Strides noted that it currently has around 60 commercialized products in the US and has set a target of launching around 20 new products per year from the combined portfolio.

Still on drug approvals, Zydus Lifesciences announced that it has received final approval from the US Food and Drug Administration to market Pemetrexed for injection, which is used to treat certain types of cancer.

According to a regulatory filing, the USFDA approved Pemetrexed for injection in strengths of 100 mg/vial, 500 mg/vial, and 1,000 mg/vial of single dose.

Pemetrexed is used to treat cancers such as lung cancer and mesothelioma.

Further to that, the USFDA has given final approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA) for Pirfenidone tablets, 267 mg and 801 mg.

According to Alembic Pharma, the approved ANDA is therapeutically equivalent to Genentech’s Reference Listed Drug (RLD) product Esbriet tablets, 267 mg and 801 mg.

Pirfenidone Tablets are used to treat Idiopathic Pulmonary Fibrosis (IPF). This ANDA had previously received preliminary approval from Alembic.

The company was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification.

It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses, the statement said.

Pirfenidone Tablets, 267 mg and 801 mg have an estimated market size of US$548 million for 12 months ending December 2021, according to IQVIA.

Alembic has settled the case with Genetech, and will launch its generic as per the terms of settlement.

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