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U.S. Department of Health and Human Services

Drugs

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Questions and Answers About FDA's Enforcement Action Against Unapproved Ophthalmic Balanced Salt Solution Products

What action is FDA taking concerning ophthalmic balanced salt solutions?

The U.S. Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS).  Individuals and firms manufacturing unapproved ophthalmic BSS must stop making these products within 60 days and stop shipping the product within 120 days.  After these dates, all ophthalmic BSS products must have FDA approval.

What is Ophthalmic BSS?

Ophthalmic BSS are sterile, isotonic, irrigating solutions used during surgical procedures on the eye.  Ophthalmic BSS for use during ocular surgery were developed in the 1960s to provide a temporary replacement for the fluid in the eye.  This enables more complex intraocular surgery techniques to be conducted that require the replacement of larger amounts of intraocular fluid.   Some of the ophthalmic BSS marketed today are designed for use in surgical procedures of limited duration, while others are appropriate for use in procedures of any expected duration. 

Why is FDA taking this action?

FDA is taking this action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and appropriately labeled.  Unapproved ophthalmic balanced salt solutions have been associated with adverse events, some of them leading to permanent loss of vision, because of contamination of the product or other product defects. 

Are there approved ophthalmic BSS products?

Two firms – Alcon Laboratories and Akorn Inc.  – have obtained approved applications for ophthalmic BSS.   Alcon’s approved products are marketed under the names “BSS” (NDA 20-742), which is intended for surgeries of under 60 minutes, and “BSS-plus” (NDA 18-469), which is intended for surgery of any expected duration.  Akorn’s approved products include “Balanced Salt Solution” (ANDA 75¬503) and “Endosol Extra” (NDA 20-079). 

Additional Information
Federal Register Notice (PDF)