New Drug Approvals Archive - November 2016

November 2016

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

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.

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.

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.