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Orphan Drugs: FDA November 2014 Approvals

December 4, 2014





The chart below identifies Orphan Drugs receiving FDA November 2014 approval as of 12/04/14 in ascending “Approval Date” order.

FDA November 2014 Orphan Products Receiving Approval

# Generic Name/Approval Date  Sponsor Company Indication
1 Ramucirumab (Cyramza)/ 11.05 Eli Lilly and Company Advanced gastric or gastro-esophageal junction adenocarcinoma, as a single agent or in combination with paclitaxel, after prior fluoropyrimidine- or platinium-containing chemotherapy
2 Bevacizumab (Avastin)/ 11.14 Genentech Combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than 2 prior chemotherapy regimens
3 Cinacalcet (Sensipar)/ 11.21 Amgen Hypercalcemia in adult patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy


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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