The company has total 120 ANDA approvals (107 final approvals and 13 tentative approvals) from USFDA.
Alembic Pharmaceuticals share price rose 3.5 percent intraday on April 20 after the company received tentative USFDA approval for its drug Alcaftadine Ophthalmic Solution, used in the prevention of itching associated with allergic conjunctivitis.
The company has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution, 0.25%, as per company release.
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, it added.
Alcaftadine had an estimated market size of $7 million for 12 months ending December 2019, according to IQVIA.
The company has total 120 ANDA approvals (107 final approvals and 13 tentative approvals) from USFDA.At 11:10 hrs Alembic Pharmaceuticals was quoting at Rs 630.55, up Rs 12.55, or 2.03 percent on the BSE.