New Molecular Entities Approved In 2012
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research.
|
Product And Sponsor |
Indication |
Date Approved (Application Number) |
|
Picato Ingenol Leo Pharma A/S |
Inducer of cell death for the topical treatment of actinic keratoses |
1/23/2012 (202833) (S) |
|
Inlyta Axitinib Pfizer Inc. |
Kinase inhibitor for treatment of advanced renal cell carcinoma after the failure of one prior systemic therapy |
1/27/2012 (202324) (S) |
|
Erivedge Vismodegib Genentech (Roche)/Curis |
Hedgehog pathway inhibitor for treatment of metastatic basal cell carcinoma or locally advanced basal cell carcinoma that has recurred following surgery or in patients who are not candidates for surgery, and are not candidates for radiation |
1/30/2012 (203388) (P) |
|
Kalydeco Ivacaftor Vertex Pharmaceuticals |
Cystic fibrosis transmembrane conductance regulator potentiator for treatment of cystic fibrosis in patients 6 years and older who have a G551D mutation in the CFTR gene |
1/31/2012 (203188) (P) |
|
Zioptan Tafluprost Merck |
Prostaglandin analog for reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
2/10/2012 (202514) (S) |
|
S: Standard review P: Priority review V: Orphan drug H: Accelerated approval |
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