New Drug Approvals Archive - January 2012

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: December 30, 2011

• FDA Expands Use of Prevnar 13 Vaccine for People Ages 50 and Older
• Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

Berinert (C1 esterase inhibitor (human))

New Indication Approved: December 22, 2011

• CSL Behring Receives FDA Approval of Expanded Label on Berinert for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
• Berinert (C1 esterase inhibitor (human)) FDA Approval History

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.

• Insys Therapeutics Announces FDA Approval of Subsys Fentanyl Sublingual Spray
• Subsys (fentanyl) FDA Approval History

Adcetris (brentuximab vedotin)

Labeling Revision Approved: January 13, 2012

• Seattle Genetics Announces Updates to Adcetris Prescribing Information
• Adcetris (brentuximab vedotin) 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.

• FDA Approves Voraxaze to Treat Patients with Toxic Methotrexate Levels
• Voraxaze (glucarpidase) FDA Approval History

Viread (tenofovir disoproxil fumarate)

Patient Population Altered: January 18, 2012

• U.S. Food and Drug Administration Approves New Formulations of Viread for Use by Children Living With HIV

Velcade (bortezomib)

New Dosage Regimen: January 23, 2012

• FDA Approves Subcutaneous Administration of Velcade In All Approved Indications

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.

• FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis
• Zetonna (ciclesonide) FDA Approval History

Vytorin (ezetimibe/simvastatin)

Labeling Revision Approved: January 24, 2012

• New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
• Vytorin (ezetimibe/simvastatin) FDA Approval History

Keppra (levetiracetam)

Patient Population Altered: December 16, 2011

• UCB Announces FDA Approval for Keppra in Infants and Children from One Month of Age with Partial Onset Seizures

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.

• FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
• 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.

• FDA Approves Inlyta for Advanced Renal Cell Carcinoma
• 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.

• FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes
• 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).

• FDA Approves Erivedge for Basal Cell Carcinoma
• 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 one mutation in the CFTR gene that is responsive to ivacaftor.

• FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis
• Kalydeco (ivacaftor) FDA Approval History

Gleevec (imatinib mesylate)

New Indication Approved: January 31, 2012

• FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer

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.

• FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes
• Jentadueto (linagliptin and metformin hydrochloride) FDA Approval History

Bydureon (exenatide)

New Dosage Form Approved: March 3, 2014

• FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes
• Bydureon (exenatide) FDA Approval History

Kalydeco (ivacaftor)

New Indication Approved: December 29, 2014

• FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation
• Kalydeco (ivacaftor) FDA Approval History

Kalydeco (ivacaftor)

New Dosage Form Approved: March 17, 2015

• FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations
• Kalydeco (ivacaftor) FDA Approval History

Jentadueto (linagliptin and metformin hydrochloride)

New Formulation Approved: May 31, 2016

• FDA Approves Once-Daily Jentadueto XR (linagliptin and metformin hydrochloride extended-release) for Type 2 Diabetes
• Jentadueto (linagliptin and metformin hydrochloride) FDA Approval History

Kalydeco (ivacaftor)

New Indication Approved: May 17, 2017

• FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis
• Kalydeco (ivacaftor) FDA Approval History

Kalydeco (ivacaftor)

New Indication Approved: July 31, 2017

• FDA Approves Kalydeco (ivacaftor) for More Than 600 People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations
• Kalydeco (ivacaftor) FDA Approval History

Bydureon (exenatide)

New Formulation Approved: October 20, 2017

• FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes
• Bydureon (exenatide) FDA Approval History

Bydureon (exenatide)

Labeling Revision Approved: April 2, 2018

• FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control
• Bydureon (exenatide) FDA Approval History