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9 New FDA Orphan Drug Designations: Week of 04/13/15

April 17, 2015





The chart below identifies 9 new FDA Products Receiving Orphan Designation for the week of 04/13/15 as of 04/17/15 in ascending “Orphan Drug Designation Date” order.

FDA Products Receiving Orphan Drug Designation (Week of 04/13/15)

# Generic Name/ODD Date Sponsor Company Indication
1 Zoledronate D,L-lysine monohydrate (ZLM)/ 04.15 Thar Pharmaceuticals Complex Regional Pain Syndrome (CRPS)
2 Selumetinib/ 04.15 AstraZeneca Pharmaceuticals Uveal Melanoma
3 Obinutuzumab/ 04.15 Genentech Follicular Lymphoma
4 Triheptanoin/ 04.15 Ultragenyx Pharmaceutical Fatty Acid Oxidation Disorders
5 Pelareorep/ 04.15 Oncolytics Biotech (Canada) Malignant Glioma
6 Diphenylcyclopropenone gel/ 04.15 RXi Pharmaceuticals Malignant melanoma stage IIB to IV
7 2-[4-[[(2-R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate/ 04.15 Cymabay Therapeutics Frederickson Type I or V hyperlipoproteinemia
8 [α−N-(2’succinyl-paclitaxel)Thr]-Phe-Phe-Tyr-Gly-Gly-Ser-Arg-Gly-[ε−N-(2’succinyl-paclitaxel)Lys]-Arg-Asn-Asn-Phe-[ε−N-(2’succinyl-paclitaxel)Lys]-Thr-Glu-Glu-Tyr / 04.15 Angiochem Brain Metastases
9 177-LU-DOTA-GlyGlyNle-CycMSHhex/ 04.16 SolaranRx Stage IIB through IV malignant melanoma


** 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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