New Indications and Dosage Forms for 2020
See also: New Drug Approvals for 2020
January 6, 2020
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
January 27, 2020
January 28, 2020
February 17, 2020
February 18, 2020
February 21, 2020
February 26, 2020
March 9, 2020
March 19, 2020
March 24, 2020
March 27, 2020
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
April 8, 2020
April 21, 2020
April 28, 2020
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
May 8, 2020
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
May 20, 2020
May 21, 2020
May 22, 2020
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
June 10, 2020
June 12, 2020
June 15, 2020
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
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
June 22, 2020
June 24, 2020
June 29, 2020
June 30, 2020
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
July 21, 2020
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
August 20, 2020
September 3, 2020
September 9, 2020
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
October 2, 2020
October 12, 2020
October 13, 2020
October 15, 2020
October 16, 2020
October 27, 2020
November 6, 2020
November 13, 2020
November 17, 2020
November 20, 2020
November 23, 2020
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
December 14, 2020
December 17, 2020
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