Department of Health and Human Services January 4, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.

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 Orion Corp. The supplemental NADA adds a claim for reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution for dogs.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for the use of doxapram hydrochloride injectable solution in dogs, cats, and horses to stimulate respiration during and after general anesthesia.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and preanesthetic in dogs.