Approvals, Launches, & New Indications

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Approvals, Launches, & New Indications

Arthritis Drug Simponi (Golimumab) Gets Expanded Indication for Ulcerative Colitis

Treatment blocks abnormal inflammatory and immune responses (May 15)

FDA Approves Radium Drug Xofigo for Metastatic Prostate Cancer

Drug delivers radiation directly to bone tumors (May 15)

FDA Approves Diagnostic Test for Lung Cancer

New use for Tarceva (erlotinib) also approved (May 14)

FDA Approves Liptruzet (Ezetimibe/Atorvastatin) to Lower Cholesterol

Drug indicated as adjunct to dietary measures (May 3)

FDA Approves Wider Indication for Sustiva (Efavirenz) in HIV-Infected Pediatric Patients

Treatment can be used in infants as young as 3 months (May 3)

Arthritis Drug Actemra (Tocilizumab) Gets Expanded Indication

Treatment approved for children with juvenile arthritis (Apr. 30)

FDA Approves Kcentra (Prothrombin Complex Concentrate) for Urgent Reversal of Anticoagulation

Product can be administered more quickly than frozen plasma (Apr. 29)

FDA Approves Diclegis for Pregnant Women Experiencing Morning Sickness

First drug for this indication in more than 30 years (Apr. 8)

FDA Approves Karbinal ER (Carbinoxamine Maleate) for Allergic Rhinitis in Children

First sustained-release histamine receptor blocker for this indication (Apr. 3)

Canagliflozin (Invokana) Gets FDA Nod for Type 2 Diabetes

First in new class of type 2 diabetes drugs (Mar. 29)

FDA Approves New Oral Contraceptive

Levonorgestrel/ethinyl estradiol tablets 97% effective in phase III trial (Mar. 29)

Tecfidera (Dimethyl Fumarate) Approved for First-Line Treatment of Relapsing MS

FDA nod based on results from two phase III trials (Mar. 27)

TOBI Podhaler Approved for Bacterial Lung Infection in CF Patients

Inhalation device contains dry-powder tobramycin (Mar. 22)

FDA Okays New MRI Agent, Dotarem (Gadoterate Meglumine)

Seventh gadolinium-based contrast agent to win approval (Mar. 20)

FDA Okays Lymphoseek to Help Locate Lymph Nodes in Cancer Patients

First node-mapping agent approved since 1981 (Mar. 13)

FDA Approval Sought for Hemophilia Therapy

Recombinant fusion protein would be first major advance in more than 20 years (Mar. 12)

FDA Approves Once-Monthly Abilify (Aripiprazole) for Schizophrenia

Extended-release formulation administered via intramuscular injection (Mar. 1)

FDA Approves Stivarga (Regorafenib) for GIST

Drug is already indicated for colorectal cancer (Feb. 25)

FDA Approves Kadcyla (Ado-Trastuzumab Emtansine) for Metastatic Breast Cancer

Drug will be available within 2 weeks (Feb. 22)

Zortress (Everolimus) Gets FDA Nod to Prevent Organ Rejection After Liver Transplant

First drug approved for this indication in more than a decade (Feb. 15)

Uceris (Budesonide) Extended-Release Tablets Launched in U.S. for Treatment of Ulcerative Colitis

Drug approved in January (Feb. 14)

FDA Approves Generic Adderall XR for Attention Deficit Disorder

Amphetamine product indicated for children, adolescents, and adults (Feb. 14)

Pomalyst (Pomalidomide) Receives FDA Nod for Advanced Multiple Myeloma

Drug accepted under agency’s accelerated approval program (Feb. 8)

FDA Approves Delzicol (Mesalamine) for Ulcerative Colitis

Launch expected in March (Feb. 5)

FDA Okays Generic Version of Cancer Drug Doxil (Doxorubicin)

Approval expected to help solve shortage problem (Feb. 4)

Epilepsy Drug Oxtellar XR (Oxcarbazepine) Launched in U.S.

Once-daily tablets indicated for adults and for children aged 6 to 17 years (Feb. 1)

FDA Approves IVIG Product Bivigam With Thrombogenic Assay

First IVIG approved with test to detect procoagulant activity (Jan. 31)

FDA Approves Kynamro (Mipomersen) for Inherited Cholesterol Disorder

First systemic antisense drug to reach the market (Jan. 29)

FDA Expands Use of Gleevec (Imatinib) to Include Children With ALL

Drug already approved for several conditions, including CML and GIST (Jan. 25)

FDA Approves Three Alogliptin Drugs for Type 2 Diabetes

Therapies indicated for blood sugar control in conjunction with diet and exercise (Jan. 25)

Vascepa (Icosapent Ethyl) Launched in U.S. for Treatment of Hypertriglyceridemia

Omega-3 drug approved as adjunct to diet (Jan. 24)

FDA Okays Over-the-Counter ‘Oxytrol for Women’ for Overactive Bladder

First OTC bladder treatment for women aged 18 years and older (Jan. 25)

Deferasirox (Exjade) Gets FDA Nod for Removal of Excess Iron in Patients With Genetic Blood Disorder

Agency also clears imaging companion diagnostic to detect liver iron concentration (Jan. 23)

FDA Approves New Use for Bevacizumab (Avastin) in Metastatic Colorectal Cancer

Drug can be continued as second-line treatment after failure of first-line therapy (Jan. 24)

FDA Okays Botox (OnabotulinumtoxinA) for Overactive Bladder

Approval expands drug’s current indications (Jan. 18)

Zecuity (Transdermal Sumatriptan) Gets FDA Nod for Acute Treatment of Migraine

First agency-approved migraine patch (Jan. 17)

FDA Approves Octaplas for Clotting Disorders

Plasma product has been in use in Europe for more than a decade (Jan. 17)

FDA Approves New Flu Vaccine

Novel production technology uses insect virus and recombinant DNA (Jan. 16)

FDA Approves Uceris (Budesonide) for Patients With Active Ulcerative Colitis

Launch scheduled for March 2013 (Jan. 14)

Urine Test for Kawasaki Disease

Proteins found in urine may enable diagnosis of rare and elusive disorder (Dec. 20)

Breathalyzer for Diagnosis of Lung Diseases

Mass spectroscopy may identify breath molecules linked to TB and cancer (Nov. 30)

Rheumatologists Cite Preferred First-Line Biologics for Psoriatic Arthritis and Ankylosing Spondylitis

Survey finds reimbursement restrictions prevent use of biologics in 30% of patients (Nov. 28)