Alembic Pharmaceuticals receives USFDA Approval Alcaftadine Ophthalmic Solution, 0.25%

Alembic Pharmaceuticals receives USFDA Approval for Alcaftadine Ophthalmic Solution, 0.25%

 

 

Alembic Pharmaceuticals Limited (Alembic) today announced it has received tentative approval
from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application
(ANDA) Alcaftadine Ophthalmic Solution, 0.25%. The approved ANDA is therapeutically
equivalent to the reference listed drug product (RLD) Lastacaft Ophthalmic Solution, 0.25%, of
Allergan, Inc. (Allergan). Alcaftadine Ophthalmic Solution is an H1 histamine receptor antagonist
indicated for the prevention of itching associated with allergic conjunctivitis.

Alcaftadine Ophthalmic Solution, 0.25% has an estimated market size of US$ 7 million for twelve
months ending December 2019 according to IQVIA.

Alembic has a cumulative total of 120 ANDA approvals (107 final approvals and 13 tentative
approvals) from USFDA.

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