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Approvals, Launches, & New Indications

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)

FDA Approves Three-Times-a-Week Copaxone (Glatiramer Acetate) for MS Patients

New dose allows less frequent injections (January 28)

FDA Approves Pennsaid 2% (Diclofenac Topical Solution) for Pain of Knee OA

First twice-daily topical NSAID for this indication (January 17)

New Lab Test Helps Hospitals Detect Drug-Resistant ‘Superbugs’

Assay identifies emerging strains of MRSA (January 13)

Farxiga (Dapaglifozin) Wins FDA Nod for Treatment of Type 2 Diabetes

Agency requires six post-marketing studies (January 8)

FDA Approves Combination Use of Mekinist (Trametinib) and Tafinlar (Dabrafenib) for Melanoma

First targeted combo therapy for patients with BRAF V600E or V600K mutations (January 9)

FDA Approves Isentress (Raltegravir) for Oral Suspension in Pediatric HIV Patients

Product also available in tablet form (January 8)

FDA Approves Recombinant Product (Tretten) for Clotting Disorder

Treatment prevents bleeding in 90% of patients in clinical study (December 23)

FDA Approves Orenitram (Extended-Release Treprostinil) for Pulmonary Arterial Hypertension

Walking distance increased versus placebo (December 20)

Company Resumes Marketing of Iclusig (Ponatinib) for Leukemia Patients

FDA okays revised prescribing information (December 21)

FEIBA Approved for Prophylactic Treatment of Hemophilia Patients

Phase III data show 72% reduction in annual bleed rate (December 19)

FDA Approves Anoro Ellipta (Umeclidinium/Vilanterol) to Treat COPD

Anticholinergic/LABA combo relieves airway obstruction (December 18)

FDA Approves First Device to Relieve Migraine Pain

Magnetic pulse stimulates occipital cortex (December 15)

FDA Approves First Generic Versions of Antidepressant Drug Cymbalta (Duloxetine)

Boxed warnings highlight suicidal thinking in young people (December 11)

FDA Approves Sofosbuvir (Sovaldi) for Treatment of Chronic Hepatitis C

Drug is third with breakthrough therapy designation to receive agency approval (December 6)

FDA Approves Scar Treatment

U.S. launch expected in first half of 2014 (December 4)

FDA Approves Velphoro for Treatment of Hyperphosphatemia in Kidney Disease Patients on Dialysis

Launch expected in 2014 (November 28)

Noxafil Delayed-Release Tablets Approved

New formulation for prevention of Aspergillus and Candida infections (November 26)

FDA Approves Varicose Vein Treatment, Varithena

Injectable foam dissolves veins as alternative to surgery (November 26)

Hepatitis C Drug Simeprevir (Olysio) Gets FDA Nod

Protease inhibitor blocks virus replication (November 22)

FDA Expands Sorafenib (Nexavar) Label to Include Treatment of Thyroid Cancer

Drug is already indicated for kidney and liver cancers (November 22)

Crizotinib (Xalkori) Granted Regular FDA Approval for Treatment of Lung Cancer

Drug received accelerated approval in 2011 (November 21)

Valchlor (Mechlorethamine) Antifungal Gel Launched in U.S.

First FDA-approved topical formulation of mechlorethamine (November 18)

Neurostimulator Device Approved to Treat Epilepsy

Monthly seizure rates reduced (November 14)

FDA Okays Luzu (Luliconazole) Antifungal Cream

Topical azole agent treats three types of infection (November 15)

FDA Approves Ibrutinib (Imbruvica) for Rare Blood Cancer

Second drug with ‘breakthrough therapy’ designation to get agency nod (November 13)

First Generic Versions of Delayed-Release Rabeprazole (AcipHex) Approved to Treat GERD

Six manufacturers get green light (November 8)

FDA Approves Aptiom (Eslicarbazepine) to Treat Seizures in Adults

Drug indicated as add-on therapy (November 8)

FDA Approves Leukemia Drug Obinutuzumab (Gazyva)

Treatment is first with breakthrough designation to receive agency nod (November 1)

Rapid HIV Diagnostic Test Now Available

New assay detects HIV earlier than antibody-only tests (October 29)

FDA Okays Long-Acting Painkiller, Zohydro ER

First to have updated labeling now required for all ER/LA opioid analgesics (October 25)

FDA Expands Sabril (Vigabatrin) Indication to Include Children With Partial Seizures

Drug is approved as adjunctive therapy (October 28)

FDA Approves Addition to Cialis (Tadalafil) Label

New phase IIIb data show efficacy in combination with finasteride (October 25)

FDA Approves Expanded Use of Entereg (Alvimopan) Following GI Surgeries

Drug is available only for short-term use in hospitalized patients (October 21)

Opsumit (Macitentan) Gets FDA Nod for Treatment of Pulmonary Arterial Hypertension

Long-term treatment delays disease progression versus placebo (October 18)

FDA Approves Fine-Particle Diclofenac (Zorvolex) for Acute Pain

Dosing strength is lower than that of other diclofenac products (October 21)