New Indications and Dosage Forms for 2008

January 2, 2008

• Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza

January 3, 2008

• FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients

January 8, 2008

• FDA Approves Cialis (tadalafil) for Once Daily Use for theTreatment of Erectile Dysfunction

January 15, 2008

• FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease

January 22, 2008

• Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis

January 23, 2008

• FDA Approves Additional Indication for Astellas' Mycamine

February 4, 2008

• FDA Approves Asmanex Twisthaler (Mometasone Furoate InhalationPowder) for the Once Daily Maintenance Treatment of Asthma inChildren Ages 4-11

February 19, 2008

• FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solutionfor the Relief of Seasonal and Year Round Allergies and ChronicIdiopathic Urticaria

February 22, 2008

• Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis

February 25, 2008

• FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer

February 28, 2008

• FDA Approves Nexium for Use in Children Ages 1-11 Years

February 29, 2008

• U.S. Food and Drug Administration Approves Abilify (aripiprazole)for the Acute Treatment of Manic and Mixed Episodes Associated WithBipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

March 3, 2008

• FDA Approves Aloxi (palonosetron HCl) Injection for Prevention ofPostoperative Nausea and Vomiting

April 23, 2008

• FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults

May 8, 2008

• FDA Approves Strattera for Maintenance of ADHD in Children and Adolescents

May 9, 2008

• Abilify (aripiprazole) Receives Expanded Indications for Maintenance Treatment in Both Pediatric Patients (Aged 10-17) With Manic and Mixed Episodes of Bipolar I Disorder and Adolescents (Aged 13-17) With Schizophrenia
• U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Add-On Treatment to Lithium or Valproate in the Acute Treatment of Adults With Manic and Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features

May 12, 2008

• FDA Approves Taclonex Scalp - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis

May 13, 2008

• FDA Approves Novo Nordisk's NovoSeven RT (Coagulation Factor VIIa[Recombinant] Room Temperature Stable) for Hemophilia Patients WithInhibitors

May 14, 2008

• FDA Approves AstraZeneca's Seroquel for Maintenance Treatment inBipolar Disorder

June 5, 2008

• FDA broadens US indication for once-yearly Reclast as only osteoporosis treatment approved for prevention of fractures after a hip fracture

June 16, 2008

• U.S. FDA Approves Requip XL, the First and Only Oral Once-DailyNon-Ergot Dopamine Agonist for Parkinson's Disease
• FDA Approves Cymbalta for the Management of Fibromyalgia

June 20, 2008

• FDA Approves GlaxoSmithKline's Avodart in Combination withTamsulosin for the Treatment of Symptomatic Enlarged Prostate

June 23, 2008

• FDA Approves Velcade (Bortezomib) for Injection for Patients withPreviously Untreated Multiple Myeloma

June 24, 2008

• New Aptivus (tipranavir) Oral Solution Approved forTreatment-Experienced Pediatric and Adolescent HIV Patients

June 27, 2008

• FDA Approves Concerta (methylphenidate HCl) Extended-releaseTablets for Treatment of ADHD (Attention Deficit HyperactivityDisorder) in Adults
• Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy

July 1, 2008

• FDA Approves Aciphex (rabeprazole sodium) 20 mg for Short-TermTreatment of GERD in Adolescents

August 1, 2008

• FDA Approves New Cardene Formulation

August 4, 2008

• Single-Pill Combinations Diovan HCT and Exforge Approved in US as First-Line Treatments for High Blood Pressure

August 11, 2008

• U.S. Food and Drug Administration Approves Viread for Chronic Hepatitis B in Adults

August 21, 2008

• Vidaza Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS

August 25, 2008

• FDA Approves Aloxi (palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting

August 26, 2008

• FDA Approves Novolog Mix 50/50

September 3, 2008

• Sandoz Receives FDA Approval for Omnitrope Pen 10 With Liquid Cartridge

September 15, 2008

• FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
• Keppra XR Approved in the U.S.
• FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States

September 23, 2008

• FDA Approves Nasacort AQ Nasal Spray for Children Aged 2-5 years old

September 24, 2008

• Teva's ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

September 29, 2008

• FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval

October 2, 2008

• U.S. Food & Drug Administration Approved the use of Reyataz (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

October 10, 2008

• FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment
• FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US

October 22, 2008

• U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1
• FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

October 29, 2008

• FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes

November 3, 2008

• Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

November 6, 2008

• Crestor Approved for Primary Dysbetalipoproteinemia
• FDA Approves Ranexa for First Line Anti Anginal Use

November 11, 2008

• EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags

November 12, 2008

• FDA Approves 30-Minute Onset of Action for Focalin XR

November 13, 2008

• FDA Approves Low-dose Regimen of Premarin Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse

December 12, 2008

• Schering-Plough Announces FDA Approval of PegIntron and Rebetol Combination Therapy for Treating Pediatric Hepatitis C

December 13, 2008

• FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, Boostrix, for Adults

December 19, 2008

• Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application
• Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote

December 22, 2008

• FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer