New Indications and Dosage Forms for 2013

January 8, 2013

• FDA approves Kineret for the treatment of NOMID

January 18, 2013

• FDA Approves Botox to Treat Overactive Bladder

January 23, 2013

• FDA Approves Exjade to Remove Excess Iron in Patients with Genetic Blood Disorder

January 25, 2013

• Pfizer Receives FDA Approval For The Use Of Prevnar 13 In Vaccine-Naive Children And Adolescents Aged 6 Years Through 17 Years For The Prevention Of Invasive Pneumococcal Disease
• FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia

February 25, 2013

• Epiduo Gel Becomes First Topical Prescription Acne Treatment Available For Children As Young As 9 Years Old
• FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors

March 26, 2013

• FDA Approves Aciphex Sprinkle (rabeprazole sodium) For Use in Children Ages 1 to 11

April 15, 2013

• Taro Receives FDA Approval For Topicort (desoximetasone) Topical Spray, 0.25%

April 23, 2013

• FDA Approves Amitiza for Opioid-Induced Constipation

April 30, 2013

• FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis
• FDA Approves Plan B One-Step Emergency Contraceptive Without a Prescription for Women 15 Years of Age and Older

May 3, 2013

• Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of Sustiva (efavirenz) in HIV-1 Infected Pediatric Patients

May 10, 2013

• Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis

May 15, 2013

• FDA Approves Tarceva (Erlotinib) Tablets and Cobas EGFR Mutation Test for Specific Type of Lung Cancer
• FDA Approves Simponi to Treat Ulcerative Colitis

June 5, 2013

• FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma

June 11, 2013

• New Fluzone Quadrivalent Four-Strain Influenza Vaccine from Sanofi Pasteur Now Licensed By FDA for Broad Age Range of Children and Adults

June 13, 2013

• FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone

June 20, 2013

• FDA Approves Plan B One-Step Emergency Contraceptive For Use Without A Prescription For All Women Of Child-Bearing Potential

June 21, 2013

• FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase
• FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia

June 24, 2013

• FDA Approves Pediatric Indication for Astellas' Mycamine (micafungin sodium) for Injection

June 28, 2013

• Novartis Exelon Patch Now FDA Approved to Treat Patients Across all Stages of Alzheimer's Disease

July 1, 2013

• Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression

July 2, 2013

• FDA Approves New U.S. Labeling for Isentress (raltegravir) to Include 240-Week Results from STARTMRK Study of Isentress Containing Regimen in Previously Untreated HIV-1 Infected Adult Patient

August 2, 2013

• FDA Expands Age Indication for Menveo

September 6, 2013

• FDA Approves Abraxane for Late-Stage Pancreatic Cancer

September 11, 2013

• FDA Approves Botox Cosmetic to Improve the Appearance of Crow’s Feet Lines

September 23, 2013

• Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis

September 24, 2013

• Purdue Pharma L.P. Receives FDA Approval For 15 mcg/hour Dosage Strength Of Butrans (buprenorphine) Transdermal System CIII

September 30, 2013

• FDA Approves Cimzia for Treatment of Adult Patients with Active Psoriatic Arthritis
• FDA Approves Perjeta for Neoadjuvant Breast Cancer Treatment

October 11, 2013

• FDA Approves Sanofi's Nasacort Allergy 24HR for Over-the-Counter Use

October 18, 2013

• Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis

October 22, 2013

• Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis

November 22, 2013

• FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer
• FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza

November 26, 2013

• FDA Approves Merck’s Noxafil Delayed-Release Tablets

December 6, 2013

• FDA Approves Xiaflex as First Drug Treatment for Peyronie’s Disease