New Drug Approvals Archive - December 2017

Ogivri (trastuzumab-dkst) for Injection

Date of Approval: December 1, 2017
Company: Mylan GmbH
Treatment for: Breast Cancer, Gastric Cancer

Ogivri (trastuzumab-dkst) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing stomach cancer.

• FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
• Ogivri (trastuzumab-dkst) FDA Approval History

Lonhala Magnair (glycopyrrolate) Inhalation Solution

Date of Approval: December 5, 2017
Company: Sunovion Pharmaceuticals Inc.
Treatment for: COPD

Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

• Sunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD
• Lonhala Magnair (glycopyrrolate) FDA Approval History

Ozempic (semaglutide) Injection

Date of Approval: December 5, 2017
Company: Novo Nordisk
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog indicated:

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

• Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
• Ozempic (semaglutide) FDA Approval History

Admelog (insulin lispro) Injection

Date of Approval: December 11, 2017
Company: Sanofi
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Admelog (insulin lispro) is a follow-on rapid-acting human insulin analog (referenced to Humalog) for the treatment of patients with type 1 and type 2 diabetes.

• FDA Approves Admelog (insulin lispro) Rapid-Acting "Follow-On" Insulin Product to Treat Diabetes
• Admelog (insulin lispro) FDA Approval History

Sinuva (mometasone furoate) Sinus Implant

Date of Approval: December 8, 2017
Company: Intersect ENT, Inc.
Treatment for: Nasal Polyps

Sinuva (mometasone furoate) is a corticosteroid-eluting sinus implant indicated for the treatment of recurrent nasal polyp disease.

• Intersect ENT Announces FDA Approval of Sinuva (mometasone furoate) Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps
• Sinuva (mometasone furoate) FDA Approval History

Ixifi (infliximab-qbtx) Injection

Date of Approval: December 13, 2017
Company: Pfizer Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Ixifi (infliximab-qbtx) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

• FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade
• Ixifi (infliximab-qbtx) FDA Approval History

Xepi (ozenoxacin) Cream

Date of Approval: December 11, 2017
Company: Medimetriks Pharmaceuticals, Inc.
Treatment for: Impetigo

Xepi (ozenoxacin) is a topical non-fluorinated quinolone for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

• Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream 1%, a Novel Topical Antibiotic for Impetigo
• Xepi (ozenoxacin) FDA Approval History

Eskata (hydrogen peroxide) Topical Solution

Date of Approval: December 14, 2017
Company: Aclaris Therapeutics, Inc.
Treatment for: Seborrheic Keratoses

Eskata (hydrogen peroxide) 40% (w/w) topical solution is a high-concentration hydrogen peroxide formulation for the treatment of raised seborrheic keratoses.

• Aclaris Therapeutics Receives FDA Approval for Eskata (hydrogen peroxide) Topical Solution, 40% (w/w) for the Treatment of Raised Seborrheic Keratoses
• Eskata (hydrogen peroxide) FDA Approval History

Prexxartan (valsartan) Oral Solution

Date of Approval: December 19, 2017
Company: Medicure Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Marketing Status: Discontinued

Prexxartan (valsartan) is an angiotensin II receptor blocker (ARB) oral solution formulation indicated for the treatment of hypertension, heart failure, and left ventricular dysfunction following myocardial infarction.

• Medicure Announces FDA Approval Received for Prexxartan (valsartan) Oral Solution
• Prexxartan (valsartan) FDA Approval History

Rhopressa (netarsudil) Ophthalmic Solution

Date of Approval: December 18, 2017
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma

Rhopressa (netarsudil ophthalmic solution) is a Rho kinase inhibitor for the treatment of open-angle glaucoma or ocular hypertension.

• Aerie Pharmaceuticals Announces U.S. FDA Approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for Patients with Open-Angle Glaucoma or Ocular Hypertension
• Rhopressa (netarsudil) FDA Approval History

Luxturna (voretigene neparvovec) Intraocular Suspension for Subretinal Injection

Date of Approval: December 19, 2017
Company: Spark Therapeutics
Treatment for: Biallelic RPE65-Mediated Inherited Retinal Disease

Luxturna (voretigene neparvovec) is an adeno-associated viral (AAV) vector gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD).

• FDA Approves Luxturna (voretigene neparvovec-rzyl) Gene Therapy to Treat Patients with a Rare Form of Inherited Vision Loss
• Luxturna (voretigene neparvovec) FDA Approval History

Macrilen (macimorelin) for Oral Solution

Date of Approval: December 20, 2017
Company: Aeterna Zentaris Inc.
Treatment for: Diagnosis of Adult Growth Hormone Deficiency

Macrilen (macimorelin) is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency.

• Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency
• Macrilen (macimorelin) FDA Approval History

Giapreza (angiotensin II) Injection - formerly LJPC-501

Date of Approval: December 21, 2017
Company: La Jolla Pharmaceutical Company
Treatment for: Hypotension, Shock

Giapreza (angiotensin II) is a synthetic human angiotensin II vasoconstrictor indicated for the treatment of hypotension in adults with septic or other distributive shock.

• FDA Approves Giapreza (angiotensin II) to Treat Dangerously Low Blood Pressure
• Giapreza (angiotensin II) FDA Approval History

Steglatro (ertugliflozin) Tablets

Date of Approval: December 19, 2017
Company: Merck
Treatment for: Diabetes, Type 2

Steglatro (ertugliflozin) is a sodium-glucose co-transporter-2 (SGLT2) inhibitor used to help improve glycemic control in adults with type 2 diabetes.

• FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes
• Steglatro (ertugliflozin) FDA Approval History

Steglujan (ertugliflozin and sitagliptin) Tablets

Date of Approval: December 19, 2017
Company: Merck & Co., Inc.
Treatment for: Diabetes, Type 2

Steglujan (ertugliflozin and sitagliptin) is a sodium glucose co-transporter 2 (SGLT2) inhibitor, and dipeptidyl peptidase-4 (DPP-4) inhibitor combination used to improve glycemic control in adults with type 2 diabetes.

• FDA Approves Steglujan (ertugliflozin and sitagliptin) for Type 2 Diabetes
• Steglujan (ertugliflozin and sitagliptin) FDA Approval History

Segluromet (ertugliflozin and metformin hydrochloride) Tablets

Date of Approval: December 19, 2017
Company: Merck & Co., Inc.
Treatment for: Diabetes, Type 2

Segluromet (ertugliflozin and metformin hydrochloride) is a sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination used to improve glycemic control in adults with type 2 diabetes.

• FDA Approves Segluromet (ertugliflozin and metformin hydrochloride) for Type 2 Diabetes
• Segluromet (ertugliflozin and metformin hydrochloride) FDA Approval History

Lumify (brimonidine tartrate) Ophthalmic Solution

Date of Approval: December 22, 2017
Company: Bausch + Lomb
Treatment for: Ocular Redness

Lumify (brimonidine tartrate) is an over-the-counter (OTC) formulation of the alpha-adrenergic agonist brimonidine indicated for use in the treatment of ocular redness.

• Bausch + Lomb Receives FDA Approval of Lumify (brimonidine tartrate) Over-the-Counter Eye Drop for the Treatment of Eye Redness
• Lumify (brimonidine tartrate) FDA Approval History