Alembic Pharmaceuticals Receives USFDA Approval
Vadodara: Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25% (OTC).
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution, 0.25%, of AbbVie Inc.
Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to:
- Pollen
- Ragweed
- Grass
- Animal hair
- Dander
Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA.
The team had earlier reported that the Company had received final approval from the USFDA for its ANDA for Bromfenac Ophthalmic Solution, 0.07%.
Read also: Alembic Pharma bags USFDA nod for Bromfenac Ophthalmic Solution
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Read also: Alembic Pharma secures USFDA nod for Seizure treatment drug Lamotrigine ER
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