New Indications and Dosage Forms for 2021
See also: New Drug Approvals for 2021
January 14, 2021
January 15, 2021
- Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer
- Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 22, 2021
February 1, 2021
- Adamas Announces FDA Approval for Second Indication for Gocovri as an Adjunctive Treatment to levodopa/carbidopa in Parkinson’s Disease Patients Experiencing OFF Episodes
- Biogen Announces FDA Approval of Plegridy (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis
February 3, 2021
February 9, 2021
February 10, 2021
February 16, 2021
February 22, 2021
February 24, 2021
March 3, 2021
March 4, 2021
March 5, 2021
March 18, 2021
March 23, 2021
March 26, 2021
March 30, 2021
March 31, 2021
April 1, 2021
- United Therapeutics Announces FDA Approval and Launch of Tyvaso for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
- FDA Approves Praluent (alirocumab) as Add-On Therapy for Patients with Homozygous Familial Hypercholesterolemia
April 7, 2021
April 12, 2021
April 13, 2021
April 16, 2021
April 19, 2021
April 30, 2021
May 1, 2021
May 5, 2021
May 6, 2021
May 20, 2021
May 27, 2021
- FDA Approves Bristol Myers Squibb’s Zeposia (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
- FDA Approves Biohaven's Nurtec ODT (rimegepant) for Preventative Treatment of Migraine
June 1, 2021
- Paratek Pharmaceuticals Announces FDA Approval of Nuzyra (omadacycline) Oral Only Dosing Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
- Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis
June 2, 2021
June 7, 2021
June 9, 2021
June 10, 2021
- Cardinal Health Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New Lymphoseek Pediatric Indication
- U.S. Food and Drug Administration Approves New Formulation of Epclusa, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C
June 16, 2021
June 21, 2021
July 1, 2021
July 6, 2021
July 9, 2021
July 20, 2021
- FDA Approves Octapharma’s Octagam 10% for Adult Dermatomyositis
- U.S. Food and Drug Administration Expands Indication for Prograf for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
July 22, 2021
July 23, 2021
- Dalvance (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients
- Bydureon BCise (exenatide extended-release) Approved in the US for the Treatment of Type 2 Diabetes in Pediatric Patients Ages 10 Years and Older
July 26, 2021
July 27, 2021
July 28, 2021
July 29, 2021
- FDA Approves Expanded Botox (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
- GSK Announces FDA Approval for Nucala (mepolizumab) for use in Adults with Chronic Rhinosinusitis with Nasal Polyps
July 30, 2021
August 11, 2021
August 12, 2021
August 16, 2021
August 17, 2021
August 18, 2021
August 20, 2021
August 23, 2021
August 25, 2021
- Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma
- FDA Approves Extension of Mirena (levonorgestrel-releasing intrauterine system) Intrauterine Device (IUD) for up to Seven Years of Pregnancy Prevention
August 30, 2021
September 1, 2021
September 15, 2021
September 17, 2021
September 22, 2021
September 24, 2021
October 1, 2021
October 11, 2021
October 13, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)
- FDA Approves Verzenio (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
October 15, 2021
- U.S. FDA Approves Cyltezo (adalimumab-adbm) as First Interchangeable Biosimilar to Humira
- FDA Approves Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer
October 18, 2021
October 20, 2021
November 5, 2021
November 18, 2021
December 9, 2021
December 14, 2021
- U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Ankylosing Spondylitis
- Rinvoq (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis
December 15, 2021
December 16, 2021
December 17, 2021
December 20, 2021
- FDA Approves Two New Indications for Xarelto (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
- FDA Approves Otezla (apremilast) for the Treatment of Adult Patients with Plaque Psoriasis, Regardless of Severity Level
- Intra-Cellular Therapies Announces U.S. FDA Approval of Caplyta (lumateperone) for the Treatment of Bipolar Depression in Adults