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