USFDA gives nod to Alembic Pharma’s generic formulation to treat itchy eyes

Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA.

USFDA gives nod to Alembic Pharma's generic formulation to treat itchy eyes
The formulation is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution, 0.25%, of AbbVie Inc. (Image Credits: Pixabay)

Alembic Pharmaceuticals Limited on Friday 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).

According to the company’s press statement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution, 0.25%, of AbbVie Inc. (AbbVie).

Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander, it added.

Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA.

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This article was first uploaded on October four, twenty twenty-four, at twenty-five minutes past two in the afternoon.
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