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New Drug Approvals Archive - September 2019

See also: New Indications and Dosage Forms for September 2019

September 2019

Gvoke (glucagon) Ready-to-Use Injection

Date of Approval: September 10, 2019
Company: Xeris Pharmaceuticals, Inc.
Treatment for: Hypoglycemia

Gvoke (glucagon injection) is a ready-to-use, room-temperature stable, liquid glucagon for the treatment of severe hypoglycemia in diabetes patients ages 2 years and older.

Ibsrela (tenapanor) Tablets

Date of Approval: September 12, 2019
Company: Ardelyx, Inc
Treatment for: Irritable Bowel Syndrome

Ibsrela (tenapanor) is a first-in-class, sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

Rybelsus (semaglutide) Tablets

Date of Approval: September 20, 2019
Company: Novo Nordisk
Treatment for: Diabetes Type 2

Rybelsus (semaglutide) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of adults with type 2 diabetes mellitus.

Jynneos (smallpox and monkeypox vaccine) Injection

Date of Approval: September 24, 2019
Company: Bavarian Nordic
Treatment for: Prevention of Smallpox; Prevention of Monkeypox

Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) is a vaccine indicated for the prevention of smallpox and monkeypox in adults.

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