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Orphan Drugs: FDA July 2014 Approvals

August 2, 2014





The chart below identifies Orphan Drugs receiving FDA July 2014 approval  as of 08/01/14 in ascending “Approval Date” order.

FDA July 2014 Orphan Products Receiving Approval

# Generic Name/Approval Date Sponsor Company Indication
1 Coagulation Factor VIIa (recombinant)/ 07.02 Novo Nordisk Bleeding episodes & peri-operative management in adults & children with Glanzmann’s thrombasthenia
2 Belinostat / 07.03 Spectrum Pharmaceuticals Peripheral T-cell Lymphoma (PTCL)
3 C1-esterase inhibitor (recombinant)/ 07.16 Pharming N.V. (Belgium) Acute Attacks of Hereditary Angioedema (HAE)
4 Dantrolene sodium suspension for injection/ 07.22 Eagle Pharmaceuticals Malignant Hyperthermia
5 Idelalisib/ 07.23 Gilead Sciences Relapsed Chronic Lymphocytic Leukemia (CLL)/ Relapsed Small Lymphocytic Lymphoma (SLL)
6 Idelalisib/ 07.23 Gilead Sciences Relapsed Follicular B-cell Non-Hodgkin Lymphoma (FL)
7 Ibrutinib/ 07.28 Pharmacyclics Chronic Lymphocytic Leukemia (CLL) with 17p deletion


Please Note: “First Pigment Analysis (5893349712)” by NASA ICE (First Pigment Analysis Uploaded by russavia) [CC-BY-2.0] | Wikimedia Commons.

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