10 New FDA-Approved Endocrinology Drugs

Glyxambi (empagliflozin and linagliptin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor combination for the treatment of adults with type 2 diabetes. Glyxambi is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments. Glyxambi is not for use in patients with type 1 diabetes. Approved 2/15. Manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company. Image: Glyxambi (R) (empagliflozin/linagliptin) tablet packaging 10/5 mg (left). Glyxambi(R) (empagliflozin/linagliptin) tablet packaging 25/5 mg (right) (PRNewsFoto/Eli Lilly and Company,Boehringer).

Natpara (parathyroid hormone) for Injection is a recombinant human parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Natpara is supplied as a multiple dose, dual-chamber glass cartridge containing a sterile lyophilized powder and a sterile diluent for reconstitution in four dosage strengths. Because of the risk of osteosarcoma, Natpara is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NATPARA REMS Program. Approved 1/15. Manufacturer, NPS Pharmaceuticals, Inc. Image source, NPS Pharamceuticals, Inc.

Somatuline Depot (lanreotide) Injection is a somatostatin analog indicated for long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy and for treatment of patients with unresectable, well- or moderately-differentiated locally advanced, or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. Approved 12/14. Manufacturer, Ipsen Pharma Biotech. Image source, Ipsen.

Signifor long-acting release (LAR) (pasireotide) for injectable suspension, for intramuscular use, is a long-acting somatostatin analog approved for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. Signifor LAR also is approved for medically naïve patients with acromegaly. Approved 12/14. Manufacturer, Novartis. Image source, http://www.newsroom.novartis.com.

Xigduo XR (dapagliflozin and metformin hydrochloride) extended release is a once-daily combination tablet of a sodium-glucose cotransporter 2 (SGLT2) inhibitor and a biguanide for the treatment of type 2 diabetes. Xigduo is approved as an adjunctive therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. Xigduo XR is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. Approved 10/14. Manufacturer, AstraZeneca. Image source, https://www.xigduoxr.com/.

Trulicity (dulaglutide injection once weekly) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Trulicity is not a substitute for insulin. Trulicity should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Approved 9/2014. Manufacturer, Eli Lilly and Company. Image source, Eli Lilly and Company.

Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained-release intravitreal implant approved to treat diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each Iluvien implant is designed to release submicrogram levels of the corticosteroid fluocinolone acetonide (FAc) for 36 months. Approved 9/2014. Manufacturer, pSivida Corp and Alimera Sciences. Image source, www.iluvien.com.

Jardiance (empagliflozin) tablets is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Jardiance is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Approved 8/2014. Manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc. Image source, www.jardiance.com

Invokamet (canagliflozin and metformin hydrochloride) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing metformin or canagliflozin or in patients already being treated with both canagliflozin and metformin. Invokamet is not for use in patients with type 1 diabetes. Approved 8/14. Manufacturer, Janssen Research & Development, LLC. Image source, http://www.drugs.com/pro/invokamet.html.

Vogelxo (testosterone) gel, for topical use, CIII is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired); hypogonadotropic hypogonadism (congenital or acquired). Approved 6/14. Manufacturer, Upsher-Smith Laboratories, Inc. Image source, http://www.vogelxo.com/about-vogelxo/package-options/.