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Approvals, Launches, & New Indications

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

Product can still be abused when taken orally

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

Phosphoinositide kinase inhibitor treats leukemia and lymphoma

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

FDA Approves Allergan’s Ozurdex for Diabetic Macular Edema

Company’s Semprana receives Complete Response Letter

Afrezza Receives FDA Approval to Treat Diabetes

Inhaled insulin is used at the start of a meal

FDA Approves Ranbaxy Subsidiary’s Generic Valsartan

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

Personal Exoskeleton Cleared by FDA for Home Use

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

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

Eloctate Gets FDA Nod for Patients With Hemophilia A

First hemophilia A therapy to extend interval between prophylactic infusions

Jublia (Efinaconazole) Receives Regulatory Approval for Treatment of Onychomycosis

Topical antifungal solution provides complete cure in some patients

FDA Approves Opioid-Dependence Drug Bunavail

First buccal film formulation of buprenorphine and naloxone

FDA Approves First Generic Versions of Celebrex (Celecoxib)

Teva and Mylan crash the party

Eye Drug Omidria (Phenylephrine/Ketorolac) Gets FDA Nod

U.S. launch expected by early fall 2014

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

Migraine Treatment Device Receives FDA Clearance

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

FDA Gives Nod to Dalvance (Dalbavancin) for Skin Infections

Treatment comparable with vancomycin in phase III trials

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

Combo treatment superior to FOLFOX alone

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

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

Subcutaneous injections help TKI nonresponders

Epanova Gets FDA Nod for Treatment of Severe Hypertriglyceridemia

First approved prescription omega-3 in free fatty acid form

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 Approves Ragwitek for Short Ragweed Pollen Allergies

Patients take sublingual tablet once daily

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

First approved treatment since H1-antihistamines

FDA Approves Otezla (Apremilast) to Treat Psoriatic Arthritis

Drug is only approved oral therapy for PsA

FDA Approves First Implantable Hearing Device for Adults With Certain Kind of Hearing Loss

Electronic device combines functions of cochlear implant and hearing aid

FDA Approves Impavido (Miltefosine) to Treat Tropical Parasitic Disease

Most U.S. patients are infected overseas

Ecoza (Econazole Nitrate) Topical Foam Launched for Treatment of Athlete’s Foot

Product approved for patients aged 12 years and older

Eliquis (Apixaban) Wins Approval to Reduce Risk of Blood Clots After Hip- or Knee-Replacement Surgery

Factor Xa inhibitor decreases thrombin generation and clot formation

FDA Approves Antifungal Agent Noxafil (Posaconazole) for IV Use

New formulation expected to be available in mid-April

FDA Approves Extended-Release Topiramate (Qudexy XR) for Seizures

Launch expected in second quarter of 2014

FDA Approves First Medical Device to Prevent Migraine Headaches

TENS headband stimulates trigeminal nerve

Oxycodone/Acetaminophen Combo Gets FDA Nod

Xartemis XR has twice-daily dosing

Otrexup (Methotrexate Injection) Launched for Treatment of Psoriasis in Adults

First subcutaneous methotrexate product for once-weekly administration

FDA Approves Injectable Testosterone Replacement Therapy, Aveed (Testosterone Undecanoate)

Product launch scheduled for March

FDA Approves Bydureon Pen (Exenatide) for Once-Weekly Treatment of Adults With Type 2 Diabetes

Device will be available later this year

FDA Approves Single-Injection Treatment for Pain of Knee OA

Decision comes 4 years after initial filing (February 25)

FDA Okays Lower-Dose NSAID, Tivorbex, for Acute Pain in Adults

Capsules contain submicron particles of indomethacin (February 24)

FDA Approves Kalydeco (Ivacaftor) for Use in Eight Additional Mutations That Cause Cystic Fibrosis

Disease results from missing or defective CFTR proteins (February 21)

FDA Approves Northera (Droxidopa) for Patients With Neurogenic Orthostatic Hypotension

Treatment carries risk of supine hypertension (February 18)

FDA Approves Vimizim (Elosulfase Alfa) to Treat Rare Congenital Enzyme Disorder

First drug to receive rare pediatric disease priority review voucher (February 14)

FDA Grants Full Approval to Synribo (Omacetaxine Mepesuccinate) for CML

Two-year postmarketing commitment completed (February 13)