Alembic gets USFDA nod for generic ophthalmic solution
- IBEF
- April 21, 2020
Alembic Pharmaceuticals had received approval from the US health regulator to market Alcaftadine ophthalmic solution, in the American market.
Tentative approval has been to the company by the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution, Alembic Pharmaceuticals said in a regulatory filing.
This approved ANDA is therapeutically equivalent to Allergan, Inc’s Lastacaft Ophthalmic Solution, 0.25 per cent.
The drug is used in the prevention of itching associated with allergic conjunctivitis in the eyes.
According to IQVIA data, Alcaftadine has an estimated market size of US$ 7 million for twelve months ending December 2019.
So far, Alembic has received a cumulative total of 120 ANDA approvals from the USFDA.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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