Alembic now has a total of 97 ANDA approvals (85 final approvals and 12 tentative approvals) from USFDA.
The share price of Alembic Pharmaceuticals gained 2.5 percent intraday Tuesday after the company received USFDA approval.
The company has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base) and 75 mg (base).
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Capsules, 30 mg (base), 45 mg (base) and 75 mg (base), of Hoffman-La Roche, Inc.
Oseltamivir Phosphate Capsules USP is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. It is also indicated for the prophylaxis of influenza A and B in patients 1 year and older.
Oseltamivir Phosphate Capsules has an estimated market size of USD 647 million for twelve months ending December 2018 according to CQ VIA.
Alembic now has a total of 97 ANDA approvals (85 final approvals and 12 tentative approvals) from USFDA.
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