Generic Treatment for Ocular Itching Approved by the FDA

Officials with the FDA have approved Alembic Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%.

The treatment is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

The approved generic treatment is therapeutically equivalent to Novartis’ Pataday Ophthalmic Solution, 0.2%, according to Alembic.

Olopatadine hydrochloride ophthalmic solution has an estimated market size of $62 million for 12 months ending December 2018, according to IQVIA.

Alembic now has a total of 93 ANDA approvals (81 final approvals and 12 tentative approvals) from FDA with the addition of the newly approved application.

Reference

Alembic· Pharmaceuticals receives USFDA Approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% [news release]. Vadodara, India; May 2, 2019: Alembic website. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/05/Press-Release-USFDA-Approval-Olopatadine-Hydrochloride-Ophthalmic-Solution-May-2019.pdf. Accessed May 2019.