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Approvals, Launches, & New Indications

FDA Approves Trulicity to Treat Type-2 Diabetes

The latest GLP-1 agonist is injected once weekly

FDA Expands Labeling for Fast-Acting Erectile Dysfunction Drug, Stendra (Avanafil)

Treatment administered within 15 minutes of sexual activity

Naloxegol (Movantik) Approved for Opioid-Related Constipation

Study evaluates potential for cardiovascular events

FDA Grants Tentative Approval to Budesonide (Uceris) Rectal Foam for Treatment of Distal Ulcerative Colitis

Launch expected in early 2015

FDA Expands Labeling for Rixubis (Coagulation Factor IX [Recombinant]) to Include Children With Hemophilia B

No bleeds in 39% of subjects receiving prophylactic treatment

FDA Approves Hyqvia (Immune Globulin Infusion 10%) for Adults With Primary Immunodeficiency

Dosing regimen requires only one monthly infusion

FDA Approves Weight-Management Pill Contrave (Naltrexone/Bupropion)

Drug may face reimbursement hurdles

Xtandi (Enzalutamide) Gets New Indication for Men With Metastatic Castration-Resistant Prostate Cancer

Treatment now approved for chemotherapy-naïve patients

Kidney Drug Ferric Citrate Approved With Warning

Treatment controls serum phosphorus levels

FDA Allows Marketing of First Test to Assess Risk of Developing Acute Kidney Injury

New method may help patient-management decisions

FDA Approves Pembrolizumab (Keytruda) for Advanced Melanoma

First anti-PD-1 therapy to get agency nod

Generic Baraclude (Entecavir) Tablets Launched in U.S.

Treatment targets hepatitis B virus infection

FDA Approves 3-D Mammography Device

SenoClaire offers improved image clarity and low radiation dose

Northera (Droxidopa) Available for Treatment of Neurogenic Orthostatic Hypotension

Only FDA-approved therapy for NOH

New Indication for Anti-Epileptic Drug Lacosamide (Vimpat)

Treatment now approved as monotherapy

Promacta (Eltrombopag) Gets Additional Indication

TPO receptor agonist now approved for aplastic anemia

New Diabetes Drug Jardiance (Empagliflozin) Now Available in U.S.

SGLT2 inhibitor blocks reabsorption of glucose in the kidney

FDA Approves Triumeq (Abacavir/Dolutegravir/Lamivudine) as Single-Pill Regimen for HIV-1 Infection

Therapy is non-inferior to Atripla

FDA Expands Eliquis Label to Include Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Treatment superior to enoxaparin/warfarin in reducing major bleeding

Asthma Drug Arnuity Ellipta (Fluticasone Furoate) Wins FDA Nod

Treatment consists of once-daily inhaled corticosteroid powder

FDA Approves First ZnT8Ab Autoantibody Test to Help Diagnose Type-1 Diabetes

Assay detects antibody in 65% of blood samples

FDA Approves Cerdelga (Eliglustat) for Gaucher Disease

Treatment targets type-1 disease in adults

FDA Grants Tentative Approval for Basaglar (Insulin Glargine Injection)

Litigation delays final O.K.

FDA Approves Plegridy (Peginterferon Beta-1a) for Treatment of Multiple Sclerosis

Relapses, disability progression, and brain lesions are reduced in phase III study

Avastin (Bevacizumab) Plus Chemotherapy Gets FDA Nod for Treatment of Advanced Cervical Cancer

First biologic/chemo combination approved for this indication

FDA Approves New Type of Sleep Drug, Belsomra (Suvorexant)

Orexin receptor antagonist alters brain signaling

FDA Approves Donor-Lung Preservation Device

System may allow more lung transplants

FDA Approves First Non-Invasive DNA Screening Test for Colorectal Cancer

CMS issues proposed national coverage determination

FDA Approves Invokamet (Canagliflozin/Metformin) for Diabetes Patients

Combo therapy has twice-daily dosing

FDA Updates Velcade (Bortezomib) Labeling to Include Retreatment in Patients with Multiple Myeloma

New label provides dosing guidelines along with safety and efficacy findings

FDA Approves Orbactiv (Oritavancin) for Skin Infections

First single-dose antibiotic for Gram-positive infections

Empagliflozin (Jardiance) Gets FDA Nod for Treatment of Type-2 Diabetes

SGLT2 inhibitor lowers blood glucose levels

Label for Lumizyme (Alglucosidase Alfa) Expanded to Include All Patients With Pompe Disease

Previous indication was for late-onset disease

FDA Approves Striverdi Respimat (Olodaterol) to Treat COPD

Beta-adrenergic agonist relaxes airway muscles

FDA Approves Eylea (Aflibercept) for Treatment of Diabetic Macular Edema

Product has indications for macular degeneration and retinal vein occlusion

FDA Expands Approved Use of Imbruvica (Ibrutinib) for CLL

New clinical data support drug’s traditional approval

FDA Approves Zydelig (Idelalisib) for Three Types of Blood Cancer

Phosphoinositide kinase inhibitor treats leukemia and lymphoma

Extended-Release Oxycodone With Abuse-Deterrent Properties Gets FDA Nod

Product can still be abused when taken orally

FDA Approves Ryanodex (Dantrolene) for Treatment of Malignant Hyperthermia

New antidote allows quicker response

Ruconest Gets FDA Nod for Treatment of Hereditary Angioedema

C1 esterase inhibitor relieves symptoms of acute angioedema attacks

FDA Approves Octagam 10% for Immune Thrombocytopenic Purpura

Product expected to be available in September

FDA Approves Rasuvo (Subcutaneous Methotrexate) for Treatment of Arthritis and Psoriasis

Product will be available in 10 dosage strengths

FDA Gives Green Light to Kerydin (Tavaborole) for Treatment of Onychomycosis

First topical therapy for toenail involvement

FDA Approves Beleodaq (Belinostat) to Treat Rare Type of Non-Hodgkin Lymphoma

Therapy helps patients with peripheral T-cell disease

First Generic Transdermal Testosterone Gel Launched in U.S.

Product is generic version of Vogelxo

Afrezza Receives FDA Approval to Treat Diabetes

Inhaled insulin is used at the start of a meal

FDA Approves Allergan’s Ozurdex for Diabetic Macular Edema

Company’s Semprana receives Complete Response Letter

Personal Exoskeleton Cleared by FDA for Home Use

New technology allows individuals with spinal cord injuries to stand & walk

FDA Approves Ranbaxy Subsidiary’s Generic Valsartan

Annual brand-name Diovan sales exceed $2 billion for Novartis

FDA Approves Sivextro to Treat Skin Infections

Among other bacteria, the drug targets methicillin-resistant strains of Staphylococcus aureus

New Insulin Delivery Device Launched in U.S.

Levemir FlexTouch contains insulin detemir

FDA Approves New Flu Test

First rapid molecular test to differentiate influenza A and B

FDA Approves Lymphoseek to Help Determine Extent of Head-and-Neck Cancer

Diagnostic agent previously approved for use in breast cancer and melanoma

FDA Approves Expanded Label for Parkinson’s Drug Azilect (Rasagiline)

Treatment can be used as adjunct to dopamine antagonists

FDA Approves Opioid-Dependence Drug Bunavail

First buccal film formulation of buprenorphine and naloxone

Jublia (Efinaconazole) Receives Regulatory Approval for Treatment of Onychomycosis

Topical antifungal solution provides complete cure in some patients

Eloctate Gets FDA Nod for Patients With Hemophilia A

First hemophilia A therapy to extend interval between prophylactic infusions

Eye Drug Omidria (Phenylephrine/Ketorolac) Gets FDA Nod

U.S. launch expected by early fall 2014

FDA Approves First Generic Versions of Celebrex (Celecoxib)

Teva and Mylan crash the party

FDA Approves First Non-Invasive Test to Help Identify Cause of Kidney Disease

Blood test targets membranous glomerulonephritis

FDA Approves First Implantable Device With Remote Monitoring to Measure PA Pressure in Heart Patients

Objective is to reduce hospitalizations for heart failure

Vectibix (Panitumumab) Plus FOLFOX Chemotherapy Receives Regulatory Approval for Treatment of Colorectal Cancer

Combo treatment superior to FOLFOX alone

FDA Gives Nod to Dalvance (Dalbavancin) for Skin Infections

Treatment comparable with vancomycin in phase III trials

Migraine Treatment Device Receives FDA Clearance

First medical device marketed in U.S. for pain caused by migraine with aura

FDA Approves First Gene-Based Test to Determine Red Blood Cell Types in Transfusion Medicine

Assay helps determine blood compatibility

FDA Approves Entyvio (Vedolizumab) to Treat Ulcerative Colitis and Crohn’s Disease

Integrin receptor antagonist achieves and maintains clinical remission

FDA Approves New Indication for Kogenate FS in Adults With Hemophilia A

Significantly fewer bleeds with prophylaxis than with on-demand treatment

FDA Approves Zontivity (Vorapaxar) to Reduce Risk of Heart Attack, Stroke in High-Risk Patients

Antiplatelet agent is first PAR-1 antagonist

Epanova Gets FDA Nod for Treatment of Severe Hypertriglyceridemia

First approved prescription omega-3 in free fatty acid form

FDA Approves CML Drug Synribo (Omacetaxine Mepesuccinate) for Home Administration

Subcutaneous injections help TKI nonresponders

FDA Approves First Sleep Apnea Implant

Neurostimulation keeps airway open

FDA Approves Incruse Ellipta (Umeclidinium) for COPD

Launch expected in fourth quarter of 2014

FDA Approves First HPV Test for Primary Cervical Cancer Screening

Test detects DNA from 14 high-risk HPV types

FDA OKs Stomach Cancer Drug Cyramza (Ramucirumab)

VEGF receptor 2 antagonist improves survival versus placebo in phase III trial

FDA OKs Arzerra (Ofatumumab) as First-Line Treatment With Chlorambucil in Patients With CLL

Combo therapy more effective at improving survival than chlorambucil alone

FDA Approves Ragwitek for Short Ragweed Pollen Allergies

Patients take sublingual tablet once daily

FDA Approves Tanzeum (Albiglutide) to Treat Type-2 Diabetes

GLP-1 receptor agonist normalizes blood sugar levels

Grass Pollen Allergy Drug Grastek Gets FDA Green Light

Sublingual treatment indicated for ages 5 through 65

FDA Approves Hand-Held Auto-Injector to Reverse Opioid Overdose

First naloxone treatment designed to be given by family members or caregivers

FDA Approves First Sublingual Allergen Extract for Grass Pollen Allergies

Treatment indicated for patients 10 through 65 years of age

FDA Approves Hemophilia Treatment Alprolix

First recombinant clotting factor therapy with prolonged circulation in the body

FDA Approves Supera Stent for Peripheral Artery Disease

Pivotal trial shows 79% stent patency rate at 1 year

FDA Approves Otezla (Apremilast) to Treat Psoriatic Arthritis

Drug is only approved oral therapy for PsA

FDA Says ‘Yes’ to Xolair (Omalizumab) for Patients With Chronic Hives

First approved treatment since H1-antihistamines