Alembic Pharma Receives USFDA Approval for Generic Influenza Drug Tamiflu
New Delhi: Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, strengthening the company's portfolio of generic products in the United States.
The company informed the stock exchanges that the approval has been granted for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, which is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Oral Suspension, 6 mg/mL, marketed by Hoffmann-La Roche, Inc.
According to the company, Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for the treatment of acute, uncomplicated influenza A and influenza B in patients aged two weeks and older who have been symptomatic for no more than 48 hours. The medicine is also indicated for the prophylaxis of influenza A and B in patients aged one year and older. The company advised healthcare professionals to refer to the product label for complete prescribing information and detailed indications.
The company stated that Oseltamivir Phosphate for Oral Suspension, 6 mg/mL has an estimated market size of US$27 million for the 12-month period ending March 2026, according to IQVIA.
According to the Alembic Pharmaceuticals press release, the latest approval increases the company's cumulative tally to 243 ANDA approvals received from the USFDA, comprising 223 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals highlighted that it is a vertically integrated research and development-driven pharmaceutical company that has been serving the healthcare sector since 1907. Headquartered in India, the company manufactures and markets generic pharmaceutical products globally, while its research and manufacturing facilities are approved by regulatory authorities in several developed markets, including the USFDA. Alembic also stated that it is among the leading companies in India's branded generics market, with its products promoted through a field force of more than 5,500 professionals.
The company added that the latest USFDA approval further expands its presence in the US generics market while strengthening its portfolio of anti-infective products.
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