Comments
Alembic Pharmaceuticals on Monday said it had received approval from the US health regulator to market Alcaftadine ophthalmic solution, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution, Alembic Pharmaceuticals said in a regulatory filing.
The approved ANDA is therapeutically equivalent to Allergan, Inc’s Lastacaft Ophthalmic Solution, 0.25 per cent.
The product is indicated for the prevention of itching associated with allergic conjunctivitis in the eyes.
According to IQVIA data, Alcaftadine has an estimated market size of USD 7 million for twelve months ending December 2019.
Alembic said it has now a cumulative total of 120 ANDA approvals from the USFDA.
Comments
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.