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Orphan Drugs: FDA February 2014 Products Receiving Approval

March 4, 2014



The chart below identifies orphan drug designated products receiving FDA approval in February 2014 (as of 03/03/14) in ascending “Approval Date” order.

FDA February 2014 Orphan Drugs Receiving Approval

  Generic Name/Approval Date Sponsor Company Indication
1 Ibrutinib (Imbruvica)/ 02.12 Pharmacyclics Chronic Llymphocytic Leukemia (CLL) who have received at least one prior therapy
2 Elosulfase Alfa (Vimizim)/ 02.14 BioMarin Pharmaceutical Mucopolysaccharidosis type IVA (Morquio A Syndrome)
3 Droxidopa (Northera)/ 02.18 Chelsea Therapeutics Symptomatic Neurogenic Orthostatic Hypotension
4 Metreleptin (Myalept)/ 02.24 Amylin Pharmaceuticals Leptin Deficiency in Patients with Congenital or Acquired Generalized Lipodystrophy


** “Generic Name/ODD Date” Column Link = Is the FDA Orphan Drug Product Designation Database Record.

Please Note: FDA Official Logo from FDA website.

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