New Drug Approvals Archive - November 2016

Enbrel (etanercept)

Patient Population Altered: November 4, 2016

• FDA Approves Expanded Use of Enbrel (etanercept) to Treat Children with Chronic Moderate-To-Severe Plaque Psoriasis

Selzentry (maraviroc)

New Formulation Approved: November 4, 2016

• ViiV Healthcare Announces FDA Approval of Selzentry (maraviroc) for Use in Children and Adolescents Living With HIV
• Selzentry (maraviroc) FDA Approval History

Vemlidy (tenofovir alafenamide) Tablets

Date of Approval: November 10, 2016
Company: Gilead Sciences, Inc.
Treatment for: Chronic Hepatitis B

Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.

• FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
• Vemlidy (tenofovir alafenamide) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: November 10, 2016

• Bristol-Myers Squibb’s Opdivo (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer
• Opdivo (nivolumab) FDA Approval History

Intrarosa (prasterone) Vaginal Inserts

Date of Approval: November 17, 2016
Company: Endoceutics Inc.
Treatment for: Dyspareunia

Intrarosa (prasterone) is a once-daily, vaginally administered steroid indicated to treat postmenopausal women experiencing moderate to severe pain during sexual intercourse (dyspareunia) as a symptom of vulvar and vaginal atrophy.

• FDA Approves Intrarosa (prasterone) for Postmenopausal Women Experiencing Dyspareunia
• Intrarosa (prasterone) FDA Approval History

FluLaval Quadrivalent (influenza virus vaccine)

Patient Population Altered: November 18, 2016

• GSK Receives FDA Approval for Expanded Indication for FluLaval Quadrivalent (Influenza Vaccine) for Infants 6 Months and Older
• FluLaval Quadrivalent (influenza virus vaccine) FDA Approval History

Darzalex (daratumumab)

New Indication Approved: November 21, 2016

• Darzalex (daratumumab) Approved by FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy
• Darzalex (daratumumab) FDA Approval History

Xultophy (insulin degludec and liraglutide) Injection - formerly IDegLira

Date of Approval: November 21, 2016
Company: Novo Nordisk
Treatment for: Diabetes Type 2

Xultophy 100/3.6 (insulin degludec and liraglutide) is a fixed-ratio combination of the long-acting basal insulin analog, insulin degludec (Tresiba), and the a glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Victoza), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

• Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes
• Xultophy (insulin degludec and liraglutide) FDA Approval History

Soliqua (insulin glargine and lixisenatide) Injection - formerly iGlarLixi

Date of Approval: November 21, 2016
Company: Sanofi
Treatment for: Diabetes Type 2

Soliqua 100/33 (insulin glargine and lixisenatide) is fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

• Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
• Soliqua (insulin glargine and lixisenatide) FDA Approval History

Veltassa (patiromer)

Labeling Revision Approved: November 25, 2016

• FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions
• Veltassa (patiromer) FDA Approval History