New Indications and Dosage Forms for 2019

January 2, 2019

• Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

January 7, 2019

• KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)

January 14, 2019

• FDA Approves Expanded Use of Adacel (Tdap) Vaccine for Repeat Vaccination
• Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma

January 23, 2019

• FDA Approves Use of 0.5 mL Dose of Fluzone Quadrivalent (influenza vaccine) in Children as Young as 6 Months of Age

January 28, 2019

• FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia

January 29, 2019

• FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause

February 12, 2019

• FDA Approves Darzalex (daratumumab) Split-Dosing Regimen

February 19, 2019

• FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection

February 25, 2019

• FDA Approves Lonsurf (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

February 26, 2019

• FDA Approves Supplemental New Drug Application to Expand Cinvanti (aprepitant) Label for IV Push

February 27, 2019

• FDA Expands Indication for Soliqua 100/33 (insulin glargine and lixisenatide injection) to Include Type 2 Diabetes Patients Uncontrolled on Oral Antidiabetic Medicines
• FDA Approves Tremfya (guselkumab) One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis

March 8, 2019

• FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

March 11, 2019

• FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents

March 18, 2019

• Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
• FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer

March 29, 2019

• FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis

April 1, 2019

• FDA Approves the Reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65

April 4, 2019

• FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer

April 11, 2019

• FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC

April 22, 2019

• FDA Approves Keytruda (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC)

April 26, 2019

• FDA Approves Praluent (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization
• GSK Receives US Approval of Benlysta for Intravenous Use in Children with Lupus Aged Five Years and Above

April 30, 2019

• FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age
• FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients

May 2, 2019

• Agios Announces FDA Approval of Tibsovo as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy

May 3, 2019

• FDA Approves Genentech's Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer

May 10, 2019

• ADMA Announces It Will Reintroduce Bivigam Into the Market

May 13, 2019

• Lilly's Cyramza (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma
• FDA Approves Eylea (aflibercept) Injection for Diabetic Retinopathy

May 14, 2019

• FDA Approves Bavencio (avelumab) Plus Inlyta (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma
• FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients

May 15, 2019

• AbbVie Announces US FDA Approval of Venclexta (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients

May 16, 2019

• FDA Approves Fragmin (dalteparin sodium) as First Anticoagulant for Venous Thromboembolism in Pediatric Patients

May 17, 2019

• FDA Approves Gattex (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)

May 22, 2019

• FDA Approves Sorilux for Adolescent Plaque Psoriasis

May 24, 2019

• FDA Approves Jakafi (ruxolitinib) for the Treatment of Patients with Acute Graft-Versus-Host Disease

May 28, 2019

• FDA Approves Expanded Use of Vraylar (cariprazine) in the Treatment of Bipolar Depression
• FDA Approves Revlimid (lenalidomide) In Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma

June 3, 2019

• FDA Approves Zerbaxa (ceftolozane and tazobactam) 3g Dose for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

June 4, 2019

• FDA Approves Emgality (galcanezumab-gnlm) for the Treatment of Episodic Cluster Headache

June 6, 2019

• Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options

June 7, 2019

• PTC Therapeutics Receives FDA Approval for the Expansion of the Emflaza (deflazacort) Labeling to Include Patients 2-5 Years of Age

June 11, 2019

• FDA Approves Keytruda (pembrolizumab) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma

June 17, 2019

• FDA Approves Victoza (liraglutide) for the Treatment of Pediatric Patients 10 Years or Older with Type 2 Diabetes

June 18, 2019

• FDA Approves Keytruda (pembrolizumab) for the Treatment of Metastatic Small Cell Lung Cancer (SCLC)

June 21, 2019

• FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
• FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene

June 24, 2019

• Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline Depot (lanreotide)
• Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery

June 26, 2019

• FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis

June 27, 2019

• FDA Approves Darzalex (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible
• Alexion Receives FDA Approval of Soliris (eculizumab) for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder
• Dova Pharmaceuticals Announces FDA Approval of Doptelet (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP)

July 15, 2019

• FDA Approves Gadavist (gadobutrol) Contrast Agent for Use in Cardiac MR in Adult Patients with Known or Suspected Coronary Artery Disease

July 19, 2019

• FDA Approves Otezla (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

July 31, 2019

• FDA Approves Keytruda (pembrolizumab) for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

August 9, 2019

• Janssen Announces U.S. FDA Accelerated Approval for Sirturo (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis

August 13, 2019

• FDA Approves Eylea (aflibercept) Injection Prefilled Syringe

August 26, 2019

• FDA Approves Taltz (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
• FDA Approves Myobloc (rimabotulinumtoxinB) Injection for Chronic Sialorrhea

September 3, 2019

• FDA Approves Juvéderm Voluma XC For Mid-Face Injection Via Cannula

September 6, 2019

• FDA Approves Ofev (nintedanib) for Interstitial Lung Disease Associated with Systemic Sclerosis or Scleroderma (SSc-ILD)

September 12, 2019

• FDA Approves Nucala (mepolizumab) for Six to 11-Year-Old Children with Severe Eosinophilic Asthma

September 17, 2019

• FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma
• FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

September 20, 2019

• Merck’s Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed

September 26, 2019

• FDA Approves Darzalex (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma

September 27, 2019

• FDA Approves Mavyret (glecaprevir/pibrentasvir) Treatment Duration of Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes
• FDA Approves Rituxan (rituximab) for Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) in Children

September 30, 2019

• FDA Approves Invokana (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes and DKD
• FDA Approves Label Update for Crysvita (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH) in Pediatric Patients 6 Months of Age and Older

October 1, 2019

• FDA Approves Entresto (sacubitril/valsartan) for Pediatric Heart Failure

October 3, 2019

• FDA Approves Descovy (emtricitabine and tenofovir alafenamide) for HIV Pre-Exposure Prophylaxis (PrEP)

October 4, 2019

• FDA Approves Fasenra Pen (benralizumab) Pre-Filled Auto-Injector for Self-Administration

October 8, 2019

• FDA Approves Octapharma’s Wilate® for Hemophilia A in Adult and Adolescent Patients

October 14, 2019

• FDA Approves Xarelto (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients

October 17, 2019

• Genentech Announces FDA Approval of Xofluza (baloxavir marboxil) for People at High Risk of Developing Influenza-Related Complications

October 18, 2019

• Nplate (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
• Alexion Receives FDA Approval for Ultomiris (ravulizumab-cwvz) for Atypical Hemolytic Uremic Syndrome (AHUS)

October 21, 2019

• FDA Approves Farxiga (dapagliflozin) to Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes
• Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

October 22, 2019

• FDA Approves Supplemental New Drug Application to Expand Cinvanti (aprepitant) Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
• FDA Approves Fiasp (insulin aspart injection) for Use in Insulin Infusion Pumps for Adults with Type 1 or Type 2 Diabetes

October 23, 2019

• FDA Approves Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer

October 24, 2019

• FDA Approves Baxdela (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
• FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy

October 28, 2019

• FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Six Years

November 4, 2019

• FDA Approves Fluzone High-Dose Quadrivalent (Influenza Vaccine) for Adults 65 Years of Age and Older

November 21, 2019

• FDA Approves Calquence for Adults with Chronic Lymphocytic Leukemia

December 3, 2019

• FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

December 12, 2019

• FDA Approves Xeljanz XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

December 13, 2019

• FDA Approves Vascepa (icosapent ethyl) to Reduce Cardiovascular Risk

December 16, 2019

• FDA Approves Xtandi (enzalutamide) for the Treatment of Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

December 30, 2019

• Lynparza (olaparib) Approved in the US as a First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer