New Drug Approvals Archive

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January 2012

January 3

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: December 30, 2011

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

January 3

Berinert (C1 esterase inhibitor (human))

New Indication Approved: December 22, 2011

Berinert (C1 esterase inhibitor (human)) FDA Approval History

January 4

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.

Subsys (fentanyl) FDA Approval History

January 13

Adcetris (brentuximab vedotin)

Labeling Revision Approved: January 13, 2012

Adcetris (brentuximab vedotin) FDA Approval History

January 17

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.

Voraxaze (glucarpidase) FDA Approval History

January 19

Viread (tenofovir disoproxil fumarate)

Patient Population Altered: January 18, 2012

January 24

Velcade (bortezomib)

New Dosage Regimen: January 23, 2012

January 20

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.

Zetonna (ciclesonide) FDA Approval History

January 25

Vytorin (ezetimibe/simvastatin)

Labeling Revision Approved: January 24, 2012

Vytorin (ezetimibe/simvastatin) FDA Approval History

January 25

Keppra (levetiracetam)

Patient Population Altered: December 16, 2011

January 23

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.

Picato (ingenol mebutate) FDA Approval History

January 27

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.

Inlyta (axitinib) FDA Approval History

January 27

Bydureon (exenatide) Extended-Release Injectable Suspension

Date of Approval: January 27, 2012
Company: Amylin Pharmaceuticals, Inc. and Alkermes plc
Treatment for: Diabetes Type 2

Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Bydureon (exenatide) FDA Approval History

January 30

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).

Erivedge (vismodegib) FDA Approval History

January 31

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 6 years and older who have a G551D mutation in the CFTR gene.

Kalydeco (ivacaftor) FDA Approval History

January 31

Gleevec (imatinib mesylate)

New Indication Approved: January 31, 2012

January 30

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.

Jentadueto (linagliptin and metformin hydrochloride) FDA Approval History

March 3

Bydureon (exenatide)

New Dosage Form Approved: March 3, 2014

Bydureon (exenatide) FDA Approval History

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