규제 업데이트

The FDA has approved Bausch & Lomb’s ophthalmic diclofenac sodium 0.1% solution (ANDA078792) for prescription use, confirming its safety and efficacy.

OCUCLEAR ophthalmic drops containing 0.025% oxyMetazoline hydrochloride have been discontinued; FDA records show a series of approved manufacturing and labeling submissions from 1986 to 2001.

FDA granted approval for ANDA079186, a generic Dorzolamide Hydrochloride ophthalmic solution submitted by AM Regent, with original approval in 2009 and a labeling supplement in 2020.

The FDA has approved Chartwell Rx's ANDA091340 for the ophthalmic solution TRAVOPROST (0.004%) as a prescription product.

The FDA records show original approval in 1974 and multiple supplemental approvals for the ophthalmic solution Naphazoline Hydrochloride, now listed as discontinued.

FDA records show Isopto Cetamide ophthalmic solution (15% sulfacetamide sodium) received several approved manufacturing and labeling submissions from 1971 to 2000; the product is now discontinued.

The FDA approved Sandoz's ANDA 076231 for a 0.3% OFLOXACIN ophthalmic solution, though the product is listed as discontinued.

Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.

The FDA granted approval for Bausch & Lomb's OFLOXACIN 0.3% ophthalmic solution (prescription) under ANDA 076622, originally approved in May 2004 with a labeling update in 2020.

FDA has approved ZADITOR, an over‑the‑counter ophthalmic solution containing 0.025% ketotifen fumarate (application ANDA077200).

The FDA approved ANDA084144 for a 0.5% proparacaine hydrochloride ophthalmic solution (drops) submitted by SOLA BARNES HIND; the product is now discontinued.

The FDA approved ANDA078598, submitted by J Molner, for a 0.3% ciprofloxacin hydrochloride ophthalmic solution. The product is listed as discontinued.