Akorn, Inc. Responds to FDA Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl

Akorn, Inc. Responds to FDA Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl

LAKE FOREST, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX) today provided the following response regarding FDA's draft guidance on vancomycin hydrochloride (HCl) capsules.

The Food and Drug Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) for vancomycin HCl capsules. Under the guidance, the FDA is currently recommending in vitro dissolution studies only for test formulations that are qualitatively and quantitatively the same as the reference listed drug with respect to inactive ingredients. This FDA draft guidance when finalized, will allow the introduction of affordable, safe and effective generic vancomycin capsules.

Arthur S. Przybyl, Akorn's President and CEO, stated, "We applaud this FDA draft guidance on vancomycin HCl capsules. The FDA's position supports our belief that in vitro dissolution studies are sufficient to determine the bioequivalence of vancomycin capsules. Akorn encourages the public to respond positively to this draft guidance within the 60 day time frame. We look forward to generic FDA approvals for vancomycin capsules that will effectively help reduce the cost of public health."

About Akorn, Inc.

Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at www.akorn.com [1].

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