New Indications and Dosage Forms for 2020

January 6, 2020

• FDA Approves Fiasp (insulin aspart injection) for the Treatment of Children with Diabetes

January 8, 2020

• FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
• FDA Approves Expanded Indication of Mycamine (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age

January 16, 2020

• FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease

January 27, 2020

• FDA Approves Merck’s Dificid (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older

January 28, 2020

• Teva Announces FDA Approval of Ajovy (fremanezumab-vfrm) Injection Autoinjector

February 17, 2020

• FDA Approves GSK’s Voltaren Arthritis Pain for Over-the-Counter Use in the United States

February 18, 2020

• Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for Procysbi (Cysteamine Bitartrate) Delayed-Release Oral Granules

February 21, 2020

• Trulicity (dulaglutide) Approved to Reduce Cardiovascular Events in Adults With and Without Established Cardiovascular Disease

February 26, 2020

• Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

March 9, 2020

• FDA Approves Ofev (nintedanib) as First Treatment for Chronic Fibrosing Interstitial Lung Diseases (ILDs) with a Progressive Phenotype

March 19, 2020

• FDA Approves Epclusa (sofosbuvir/velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection

March 24, 2020

• FDA Approves Eucrisa (crisaborole) Ointment 2% in Children as Young as 3 Months of Age With Mild-to-Moderate Atopic Dermatitis

March 27, 2020

• FDA Approves Triferic AVNU (ferric pyrophosphate citrate), Intravenous Formulation of Triferic for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients

March 30, 2020

• Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
• Imfinzi (durvalumab) Approved in the US for Extensive-Stage Small Cell Lung Cancer

April 3, 2020

• FDA Approves Reblozyl (luspatercept-aamt) to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

April 8, 2020

• FDA Approves Braftovi (encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy

April 21, 2020

• FDA Approves Imbruvica (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

April 28, 2020

• FDA Approves Merck’s Keytruda (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications

April 29, 2020

• FDA Approves Ortho Dermatologics' Labeling for Jublia (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old
• FDA Approves Zejula (niraparib) as the Only Once-Daily PARP Inhibitor in First-Line Monotherapy Maintenance Treatment for Women with Platinum-Responsive Advanced Ovarian Cancer Regardless of Biomarker Status

May 6, 2020

• Farxiga Approved in the US for the Treatment of Heart Failure in Patients with Heart Failure with Reduced Ejection Fraction

May 8, 2020

• Lynparza (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer

May 15, 2020

• Rubraca (rucaparib) Approved in the U.S. as Monotherapy Treatment for Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Pomalyst (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma
• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%

May 18, 2020

• FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer

May 20, 2020

• Lynparza Approved in the US for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

May 21, 2020

• Chiesi Group Receives FDA Approval for Ferriprox (deferiprone) Twice-a-Day Tablets

May 22, 2020

• FDA Approves Takeda’s Alunbrig (brigatinib) as a First-Line Treatment Option for Patients with ALK+ Metastatic Non-Small Cell Lung Cancer (NSCLC)

May 26, 2020

• FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis
• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer

May 27, 2020

• FDA Approves VESIcare LS (solifenacin succinate) Oral Suspension for Neurogenic Detrusor Overactivity (NDO) Pediatric Patients
• FDA Approves New Pediatric Formulation of Sirturo (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis

May 29, 2020

• FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With Hepatocellular Carcinoma
• Lilly's Cyramza (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

June 1, 2020

• Brilinta Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease
• Lilly's Taltz (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

June 5, 2020

• FDA Approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

June 10, 2020

• FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy

June 12, 2020

• FDA Approves Tivicay PD (dolutegravir) Once-Daily Dispersible Tablet Formulation for Children with HIV

June 15, 2020

• FDA Approves Merck’s Gardasil 9 for the Prevention of Certain HPV-Related Head and Neck Cancers

June 16, 2020

• Cosentyx Receives FDA Approval for New Indication to Treat Active Non-Radiographic Axial Spondyloarthritis
• Ilaris (canakinumab) Receives FDA Approval for New Indication to Treat Adult-Onset Still’s Disease (AOSD)

June 17, 2020

• FDA Approves Second Biomarker-Based Indication for Merck’s Keytruda (pembrolizumab), Regardless of Tumor Type

June 18, 2020

• Epizyme Announces U.S. FDA Accelerated Approval of Tazverik (tazemetostat) for Relapsed/Refractory Follicular Lymphoma
• Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO)

June 19, 2020

• FDA Approves New Dupixent (dupilumab) Pre-Filled Pen Designed to Support More Convenient Self-Administration

June 22, 2020

• Karyopharm Announces FDA Approval of Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

June 24, 2020

• FDA Approves Merck’s Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation

June 29, 2020

• FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

June 30, 2020

• FDA Approves Bavencio as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

July 9, 2020

• FDA Approves Expanded Botox (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity
• Ipsen Announces Updated Indication for Dysport (abobotulinumtoxinA) for the Treatment of Spasticity in Children

July 14, 2020

• Tremfya (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis

July 21, 2020

• Averitas Pharma Announces FDA Approval of Qutenza for the Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy of the Feet

July 30, 2020

• FDA Approves Stelara (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
• FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma

August 3, 2020

• FDA Approves Spravato (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
• FDA Approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex

August 6, 2020

• ViiV Healthcare Announces FDA Approval of an Expanded Indication for Dovato (dolutegravir/lamivudine), a Complete Two-Drug Regimen for Virologically Suppressed Adults with HIV-1

August 20, 2020

• FDA Approves New Kyprolis (carfilzomib) Combination Regimen with Darzalex (daratumumab) and Dexamethasone in Both Once- And Twice-Weekly Dosing Regimens

September 3, 2020

• FDA Approves Additional Doses of Trulicity (dulaglutide) for the Treatment of Type 2 Diabetes

September 9, 2020

• FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of Asthma

September 25, 2020

• FDA Approves Nucala (mepolizumab) as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
• FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age

September 28, 2020

• U.S. FDA Approves Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients (patients 6 years of age and older).
• FDA Approves Fetroja (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
• U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
• FDA Approves Bausch + Lomb Alaway Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%

September 30, 2020

• Simponi Aria (golimumab) Approved by the FDA for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older

October 2, 2020

• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

October 12, 2020

• Alexion Receives FDA Approval for New Advanced Formulation of Ultomiris (ravulizumab-cwvz) with Significantly Reduced Infusion Time

October 13, 2020

• Harmony Biosciences Receives FDA Approval for Expanded Use of Wakix (pitolisant) for the Treatment Of Cataplexy in Adult Patients with Narcolepsy

October 15, 2020

• FDA Approves Expanded Indication for Merck’s Keytruda (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

October 16, 2020

• Genentech Announces Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia

October 27, 2020

• FDA Approves Sklice (ivermectin) Lotion for Nonprescription Use to Treat Head Lice

November 6, 2020

• Brilinta Approved in the US to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

November 13, 2020

• FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)

November 17, 2020

• Vimpat (lacosamide) Now Approved by FDA for Primary Generalized Tonic-Clonic Seizures and Expanded Pediatric Use for People Living with Epilepsy

November 20, 2020

• Imfinzi Approved in the US for Less-Frequent, Fixed-Dose Use

November 23, 2020

• Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person

December 1, 2020

• Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers
• FDA Approves Hetlioz (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome
• Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps

December 4, 2020

• FDA Approves Saxenda (liraglutide) for the Treatment of Obesity in Adolescents Aged 12-17

December 14, 2020

• FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis

December 17, 2020

• FDA Approves GSK’s Benlysta as the First Medicine for Adult Patients with Active Lupus Nephritis in the US

December 18, 2020

• Karyopharm Announces FDA Approval of Xpovio (selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy
• FDA Approves Supplemental New Drug Application for Takeda’s Iclusig (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML

December 21, 2020

• FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea
• Vertex Announces FDA Approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for Use in People With CF With Certain Rare Mutations
• Tagrisso Approved in the US for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Non-Small Cell Lung Cancer

December 22, 2020

• FDA Approves Kineret (anakinra) for the Treatment of Deficiency of IL-1 Receptor Antagonist (DIRA)

December 29, 2020

• Bristol Myers Squibb Statement on Opdivo (nivolumab) Small Cell Lung Cancer U.S. Indication