Alembic Pharma Gets USFDA Tentative Nod For Alcaftadine Ophthalmic Solution

Alembic Pharma Gets USFDA Tentative Nod For Alcaftadine Ophthalmic Solution

Overview

  • Post By : Kumar Jeetendra

  • Source: Agencies

  • Date: 21 Apr,2020

Alembic Pharmaceuticals Limited has reported that it has gotten provisional endorsement from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25%. The endorsed ANDA is remedially equal to the reference recorded medication item (RLD) Lastacaft Ophthalmic Solution, 0.25%, of Allergan, Inc. (Allergan). Alcaftadine Ophthalmic Solution is a H1 histamine receptor foe showed for the avoidance of tingling related with hypersensitive conjunctivitis.

Alcaftadine Ophthalmic Solution, 0.25% has an expected market size of US$ 7 million for a year finishing December 2019 as per IQVIA. Alembic has a combined aggregate of 120 ANDA endorsements (107 last endorsements and 13 provisional endorsements) from USFDA. Alembic Pharmaceuticals Limited, a vertically incorporated innovative work pharmaceutical organization, has been at the cutting edge of human services since 1907. Headquartered in India, Alembic is a freely recorded organization that fabricates and advertises nonexclusive pharmaceutical items everywhere throughout the world.

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