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U.S. Department of Health and Human Services


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Questions and Answers About FDA's Enforcement Action Against Unapproved Freshkote Sterile Ophthalmic Solution

The Food and Drug Administration (FDA) has sent Warning Letters to Altaire Pharmaceuticals, Inc. manufacturer, and Focus Labs, Inc. distributor, of Freshkote® Sterile Ophthalmic Solution an unapproved drug marketed as a prescription drug to be used for dry eye. This drug is manufactured and distributed under NDC 15821-0101-15. 

Why is FDA taking this action?

FDA is taking this action as part of its continuing effort to ensure that drugs marketed in the U.S. have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and appropriately labeled. 

What does this mean for the companies that received the Warning Letters?

Altaire Pharmaceuticals, Inc. has 90 days after the date of its Warning Letter to stop manufacturing unapproved new drugs. Focus Labs, Inc. has 180 days after the date of its Warning Letter to stop distributing existing drugs.  If firms continue manufacture or distribution of these drugs after these grace periods, FDA may proceed immediately to enforcement action, including but not limited to, seizure and injunction.

In addition, unapproved drug products that are introduced onto the market after September 19, 2011 are subject to immediate enforcement action without prior notice and without regard to the priorities listed in the CPG. Guidance for Industry: Marketed Unapproved Drugs - Compliance Policy Guide (PDF) 

What effect will FDA’s action have on people who use Freshkote® Sterile Ophthalmic Solution? Are there alternatives?

There are many non-prescription drugs on the market that consumers can use for dry eye.  While these drugs do not require FDA approval, they must conform to FDA standards for safety, effectiveness and quality.

Should I keep taking my medications?

Consumers who have concerns about their medications should speak to their healthcare professionals about replacements.