February 26, 2015
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
* Binosto alendronate sodium Tablet, Effervescent;Oral Mission Pharma Labeling Revision
* Cisplatin cisplatin Injectable;Injection Hq Spclt Pharma Labeling Revision
* Firmagon degarelix acetate Powder;Subcutaneous Ferring Labeling Revision
* Kynamro mipomersen sodium Solution;Subcutaneous Genzyme Corp Labeling Revision
*.Neupro rotigotine Film, Extended Release;Transdermal Ucb Inc Labeling Revision
* Pediatric Advil ibuprofen Suspension/Drops;Oral Pfizer Manufacturing Change or Addition
* Platinol cisplatin Injectable;Injection Hq Spclt Pharma Labeling Revision
* Platinol-Aq cisplatin Injectable;Injection Hq Spclt Pharma Labeling Revision
* Prolia denosumab Injectable; Subcutaneous Amgen Labeling Revision
* Reyataz atazanavir sulfate Capsule;Oral Bristol Myers Squibb Labeling Revision
* Suprane desflurane Liquid;Inhalation Baxter Hlthcare Labeling Revision
* Torisel temsirolimus Solution;Intravenous Pf Prism Cv Labeling Revision
* Xgeva denosumab Injectable; Subcutaneous Amgen Labeling Revision