New Drug Approvals Archive - January 2012
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See also: New Indications and Dosage Forms for January 2012
January 2012
Subsys (fentanyl) Sublingual Spray
Date of Approval: January 4, 2012
Company: INSYS Therapeutics, Inc.
Treatment for: Pain
Subsys (fentanyl) is an opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.
Voraxaze (glucarpidase) Injection
Date of Approval: January 17, 2012
Company: BTG International Inc.
Treatment for: Toxic Methotrexate Levels
Voraxaze (glucarpidase) is a carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function.
Zetonna (ciclesonide) Nasal Aerosol
Date of Approval: January 20, 2012
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Allergic Rhinitis
Zetonna (ciclesonide) is corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis.
Picato (ingenol mebutate) Topical Gel
Date of Approval: January 23, 2012
Company: Leo Pharma
Treatment for: Actinic Keratosis
Picato (ingenol mebutate) is an inducer of cell death indicated for the topical treatment of actinic keratosis.
Inlyta (axitinib) Tablets
Date of Approval: January 27, 2012
Company: Pfizer Inc.
Treatment for: Renal Cell Carcinoma
Inlyta (axitinib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
Bydureon (exenatide) Extended-Release Injectable Suspension
Date of Approval: January 27, 2012
Company: AstraZeneca
Treatment for: Diabetes Type 2
Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients with type 2 diabetes.
Erivedge (vismodegib) Capsules
Date of Approval: January 30, 2012
Company: Genentech
Treatment for: Basal Cell Carcinoma
Erivedge (vismodegib) is a hedgehog pathway inhibitor for the treatment of patients with advanced basal cell carcinoma (BCC).
Kalydeco (ivacaftor) Tablets and Oral Granules
Date of Approval: January 31, 2012
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients ages one year and older who have one mutation in the CFTR gene that is responsive to ivacaftor.
Jentadueto (linagliptin and metformin hydrochloride) Tablets
Date of Approval: January 30, 2012
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly
Treatment for: Diabetes Type 2
Jentadueto (linagliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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