Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac

• Date: November 04, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplemental NADA provides for a revised human food safety warning for use of diclofenac sodium topical cream in horses.

Effective Date: This rule is effective September 16, 2009

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