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8 New FDA Orphan Drug Designations: Week of 05/11/15

May 18, 2015





The chart below identifies 8 new FDA Products Receiving Orphan Designation for the week of 05/11 – 05/15/15 as of 05/18/15 in ascending “Orphan Drug Designation Date” order.

FDA Products Receiving Orphan Drug Designation (Week of 05/11 – 05/15/15)

 # Generic Name/ODD Date Sponsor Company Indication
1 Edaravone/ 05.12 Mitsubishi Tanabe Pharma (Japan) ALS
2 N-t-butylhydroxylamine/ 05.12 Andrew Lim (California Institute of Technology) Infantile neuronal ceroid lipofuscinosis
3 Recombinant human alkaline phosphatase/ 05.13 AM-Pharma BV (Netherlands) Hypophosphatasia
4 E-selectin antagonist/ 05.13 GlycoMimetics Acute Myeloid Leukemia (AML)
5 Bruton’s Tyrosine Kinase (Btk) Inhibitor/ 05.13 Acerta Pharma BV (Netherlands) Chronic lymphocytic leukemia (CLL)
6 Anti-eTau Humanized IgG4 Monoclonal Antibody/ 05.13 BMS Progressive Supranuclear Palsy
7 Hydrocortisone oral granules/ 05.13 Diurnal Limited (UK) Pediatric adrenal insufficiency (0-16 years of age)
8 Adalimumab/ 05.13 AbbVie Moderate to severe hidradenitis suppurativa (Hurley stage 2 & 3)


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

Please Note : “Two small test tubes held in spring clamps” courtesy of  Amitchell125 at English Wikipedia [CC-BY-SA-30] | Wikimedia Commons.

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