Article

FDA approves generic levofloxacin

The FDA has granted final approval to Hi-Tech Pharmacal Co. Inc. for the company's abbreviated new drug application for levofloxacin ophthalmic solution 0.5%, the generic for a proprietary ophthalmic solution (Quixin, Vistakon). The product is indicated for bacterial conjunctivitis.

Amityville, NY-The FDA has granted final approval to Hi-Tech Pharmacal Co. for the company's abbreviated new drug application for levofloxacin ophthalmic solution 0.5%, the generic version of a proprietary ophthalmic solution (Quixin, Vistakon). The product is indicated for bacterial conjunctivitis.

The proprietary ophthalmic solution had sales of $2 million for the 12 months ended in December 2010, according to IMS sales data. Hi-Tech Pharmacal is preparing to launch its generic version by the end of March 2011.

Hi-Tech Pharmacal is a specialty pharmaceutical company manufacturing generic and branded prescription and over-the-counter products. According to the company, it has 15 products awaiting approval at the FDA and targeting brand and generic sales of more than $1.0 billion, as well as 20 products in active development targeting brand sales of more than $2 billion, including sterile ophthalmic products.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
Lisa Nijm, MD, says preoperative osmolarity testing can manage patient expectations and improve surgical results at the 2025 ASCRS annual meeting
At the 2025 ASCRS Annual Meeting, Weijie Violet Lin, MD, ABO, shares highlights from a 5-year review of cross-linking complications
Maanasa Indaram, MD, is the medical director of the pediatric ophthalmology and adult strabismus division at University of California San Francisco, and spoke about corneal crosslinking (CXL) at the 2025 ASCRS annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Taylor Strange, DO, assesses early visual outcomes with femto-created arcuate incisions in premium IOL cases
(Image credit: Ophthalmology Times) ASCRS 2025: Neda Shamie, MD, shares her early clinical experience with the Unity VCS system
Patricia Buehler, MD, MPH, founder and CEO of Osheru, talks about the Ziplyft device for noninvasive blepharoplasty at the 2025 American Society of Cataract and Refractive Surgeons (ASCRS) annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Bonnie An Henderson, MD, on leveraging artificial intelligence in cataract refractive surgery
(Image credit: Ophthalmology Times) ASCRS 2025: Gregory Moloney, FRANZO, FRCSC, on rotational stability
Sheng Lim, MD, FRCOphth, discusses the CONCEPT study, which compared standalone cataract surgery to cataract surgery with ECP, at the 2025 ASCRS Annual Meeting.
(Image credit: Ophthalmology Times) ASCRS 2025: Steven J. Dell, MD, reports 24-month outcomes for shape-changing IOL
© 2025 MJH Life Sciences

All rights reserved.