USFDA gives final nod to Alembic Pharmaceuticals’ Glaucoma drug

Alembic Pharmaceuticals Limited on Thursday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate Ophthalmic Solution, 0.15%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Alphagan P Ophthalmic Solution, 0.15%, of AbbVie Inc. Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist.

This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness.

Also Read

Why novel drug delivery systems are taking centre stage in the pharmaceutical industry?

This medicated eye drop can prevent myopia among kids; Read on to find out more

Dr. Reddy’s successfully completes Phase I study of its proposed biosimilar of immunosuppressive drug

Redefining the pharmaceutical industry’s role in combating climate change

Brimonidine Tartrate Ophthalmic Solution, 0.15% has an estimated market size of US$ 97 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.