FDA Actions in Brief May 2012


Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)

Azelastine and fluticasone (Dymista, Meda) was approved for the treatment of seasonal allergic rhinitis.

Insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) has expanded its pediatric indication and was approved for use for children aged 2 to 5 years old with type 1 diabetes. It is the first and only basal insulin analog approved for use in patients as young as age 2 years.

Levofloxacin (Levaquin, Janssen) was approved to treat plague, a rare and potentially deadly bacterial infection. Levaquin also was approved to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.

Foscarnet sodium (Foscavir, Clinigen) was approved for the treatment of HIV/AIDS-related cytomegalovirus infections and herpes.

Tazarotene (Fabior Foam 0.1%, GlaxoSmithKline) was approved for the treatment of acne vulgaris in patients 12 years of age and older.

Acetazolamide for injection USP (Strides Arcolab), 500-mg vial (preservative-free) in lyophilized format was approved for the adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.

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