Orphan Drugs: FDA November 2014 Approvals
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|
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