New Drug Approvals Archive - December 2017

Repatha (evolocumab)

New Indication Approved: December 1, 2017
Treatment for: High Cholesterol; Prevention of Heart Attack and Stroke

• FDA Approves Amgen's Repatha (evolocumab) to Prevent Heart Attack and Stroke
• Repatha (evolocumab) FDA Approval History

Taltz (ixekizumab)

New Indication Approved: December 1, 2017

• Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis
• Taltz (ixekizumab) FDA Approval History

Ogivri (trastuzumab-dkst)

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

Avastin (bevacizumab)

Labeling Revision Approved: December 5, 2017

• FDA Grants Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer
• Avastin (bevacizumab) FDA Approval History

Lonhala Magnair (glycopyrrolate) Inhalation Solution

Date of Approval: December 5, 2017
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

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

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the treatment of adults with type 2 diabetes.

• 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

Omidria (ketorolac and phenylephrine)

Patient Population Altered: December 12, 2017
Treatment for: Intraocular Lens Replacement Procedures

• Omeros Corporation Announces FDA Approval of Omidria for Use in Pediatric Patients
• Omidria (ketorolac and phenylephrine) FDA Approval History

Nucala (mepolizumab)

New Indication Approved: December 12, 2017

• FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)
• Nucala (mepolizumab) 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

Xeljanz (tofacitinib)

New Indication Approved: December 14, 2017

• Pfizer Announces FDA Approval of Xeljanz (tofacitinib) and Xeljanz XR for the Treatment of Active Psoriatic Arthritis
• Xeljanz (tofacitinib) 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: Hypertension, Congestive Heart Failure, Left Ventricular Dysfunction

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

Cabometyx (cabozantinib)

New Indication Approved: December 19, 2017

• Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Untreated Advanced Renal Cell Carcinoma
• Cabometyx (cabozantinib) FDA Approval History

Bosulif (bosutinib)

New Indication Approved: December 19, 2017

• FDA Approves Pfizer’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)
• Bosulif (bosutinib) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: January 20, 2018

• Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease
• Opdivo (nivolumab) FDA Approval History

Perjeta (pertuzumab)

New Indication Approved: December 20, 2017

• FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer
• Perjeta (pertuzumab) 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

Tasigna (nilotinib)

New Dosage Regimen: December 22, 2017

• FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response
• Tasigna (nilotinib) 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