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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 Fluorescein Injection

What action is FDA taking regarding Fluorescein Injection?

The Food and Drug Administration (FDA) has sent Warning Letters to the manufacturer and distributor of unapproved Fluorescein Injection, a dye injected into the vein for evaluation of eye conditions. There are FDA approved versions of this drug on the market for use in “diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.” See Table 1.

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.  Hub Pharmaceuticals 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 the use of Fluorescein Injection? Are there alternatives?

Practitioners will continue to have access to FDA-approved Fluorescein Injection.  Two firms market FDA-approved Fluorescein Injection available in 10%. One firm also has approval for 25% should it be needed.  See Table 2. FDA has reached out to these firms who assured us they can meet market demand with their approved drugs.

How can people tell the difference between FDA-approved and unapproved products?

While the FDA works to ensure that all marketed unapproved drugs obtain approval or are removed from the market, FDA provides various resources that list approved drugs. Healthcare practitioners and consumers can search Drugs@FDA or The Orange Book to determine whether a drug is FDA-approved.  Drugs@FDA contains most FDA-approved drug products.  In the Orange Book, if the drug is FDA approved, then the search results display the application number "Appl No", followed by active ingredient, dosage form/route, strength, proprietary name, and applicant. If the drug is not approved, the results will state "No matching records found."


Table 1.  List of Unapproved Fluorescein Injection Subject to Warning Letters

Firm

Fluorescein Lite 25%

 

Altaire Pharmaceuticals, Inc. (Altaire)

59390-0187-02

Fluorescein Lite 10%

Altaire

59390-0188-05

Fluorescein Sodium Injection 25%

Altaire

59390-0200-02

Fluorescein Sodium Injection 10%

Altaire

59390-0199-05

 

 

 

Fluorescein Injection U.S.P. Lite 10%

Hub Pharmaceuticals

17238-0301-05

Fluorescein Injection U.S.P. Lite 25%

Hub Pharmaceuticals

17238-0401-02

 

Table 2.  List of FDA-Approved Fluorescein Injection

NDA#

Fluorescite® 10%

Alcon Laboratories

00065-0092-65

021980

AK-Fluor® 10%

AK-Fluor® 25%

Akorn, Inc.

Akorn, Inc.

17478-0253-10

022186

022186