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New Drug Approvals Archive - 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.

Viread (tenofovir disoproxil fumarate)

Patient Population Altered: January 18, 2012

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.

Gleevec (imatinib mesylate)

New Indication Approved: January 31, 2012

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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