7 New Medical Entities Approved by FDA in Q1 2010

1. ACTEMRA (Tocilizumab) by Genentech
   FDA Application number: BLA # 125276; Approval Date: 1/8/2010
   ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor indicated for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
   Dosage: Once every 4 week as 60 m intravenous drip of 4 or 8 mg/Kg.
   Prescribing Information: http://www.gene.com/gene/products/information/actemra/pdf/pi.pdf
2. AMPYRA (Dalfampridine) by Acorda Therapeutics
   FDA Application number: NDA # 022250; Approval Date: 1/22/2010
   AMPYRA (dalfampridine) is a potassium channel blocker indicated to improve walking in patients with multiple sclerosis (MS).
   Dosage: 10 mg twice daily.
   Prescribing Information: http://www.ampyra.com/local/files/PI.pdf
3. VICTOZA (Liraglutide) by Novo Nordisk
   FDA Application number: NDA # 022341; Approval Date: 1/25/2010
   VICTOZA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
   Dosage: Once daily 0.6, 1.2 or 1.8 mg subcutaneous injection.
   Prescribing Information: http://www.victoza.com/pdf/PI_(1_Column_Format).pdf
4. XIAFLEX (Collagenase clostridium histolyticum) by Auxilium Pharmaceuticals
   FDA Application number: BLA # 125338; Approval Date: 2/2/2010
   XIAFLEX is indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord.
   Dosage: 0.58mg per intralesional injection.
   Prescribing Information: http://www.xiaflex.com/docs/pi_medguide_combo.pdf
5. VPRIV (Velaglucerase alfa) by Shire
   FDA Application number: NDA # 022575; Approval Date: 2/26/2010
   VPRIV (velaglucerase alfa for injection) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease.
   Dosage: 60U/kg administered every other week as a 60 min intravenous infusion.
   Prescribing Information: http://medicuslb.com/dev/vpriv/staging/VPRIV_Full_Prescribing_Info.pdf
6. CARBAGLU (Carglumic acid) by Recordati
   FDA Application number: NDA # 022562; Approval Date: 3/18/2010
   CARBAGLU (Carglumic acid) is a Carbamoyl Phosphate Synthetase 1 (CPS 1) activator is indicated as an adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).
   Dosage: 100 mg/kg/day to 250 mg/kg/day.
   Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf
7. ASCLERA (Polidocanol) by Chemische Fabrik Kreussler
   FDA Application number: NDA # 021201; Approval Date: 3/30/2010
   ASCLERA (Polidocanol) is a sclerosing agent indicated to treat uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity.
   Dosage: Up to 10 ml of 0.5-1.0% solution by intravenous injection.
   Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf