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New Drug Approvals Archive - January 2012

January 2012

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: December 30, 2011

Read more: Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

Subsys (fentanyl) Sublingual Spray - formerly Fentanyl SL 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.

Read more: Subsys (fentanyl) FDA Approval History

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.

Read more: Voraxaze (glucarpidase) FDA Approval History

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.

Read more: Zetonna (ciclesonide) FDA Approval History

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.

Read more: Picato (ingenol mebutate) FDA Approval History

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.

Read more: Inlyta (axitinib) FDA Approval History

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.

Read more: Bydureon (exenatide) FDA Approval History

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).

Read more: Erivedge (vismodegib) FDA Approval History

Kalydeco (ivacaftor) Tablets

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 age 2 years and older who have the G551D or R117H mutations in the CFTR gene.

Read more: Kalydeco (ivacaftor) FDA Approval History

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.

Read more: Jentadueto (linagliptin and metformin hydrochloride) FDA Approval History

New Drug Approvals Archive