New Indications and Dosage Forms for 2021

January 14, 2021

• Pfizer’s Xalkori (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults

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

• FDA Approves Opdivo (nivolumab) in Combination with Cabometyx (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma

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

• BioCryst Announces FDA Approval of Supplemental New Drug Application for Rapivab Expanding Patient Population to Include Children Six Months and Older

February 9, 2021

• FDA Approves Libtayo (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma

February 10, 2021

• Botox (onabotulinumtoxinA) Receives FDA Approval for Pediatric Detrusor Overactivity Associated with a Neurologic Condition

February 16, 2021

• Entresto Granted Expanded Indication in Chronic Heart Failure by FDA

February 22, 2021

• FDA Approves Libtayo (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-Small Cell Lung Cancer with PD-L1 Expression of ≥50%

February 24, 2021

• Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

March 3, 2021

• U.S. FDA Expands Approval of Pfizer’s Lorbrena as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

March 4, 2021

• Genentech’s Actemra Becomes the First Biologic Therapy Approved by the FDA for Slowing the Rate of Decline in Pulmonary Function in Adults With Systemic Sclerosis-Associated Interstitial Lung Disease, a Rare, Debilitating Condition

March 5, 2021

• U.S. FDA Approves Yescarta for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy

March 18, 2021

• Kiniksa Announces FDA Approval of Arcalyst (rilonacept) for Recurrent Pericarditis

March 23, 2021

• FDA Approves Merck’s Keytruda (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma

March 26, 2021

• FDA Approves New Indication & New Product Formulation for Myrbetriq for Use in Children with Neurogenic Detrusor Overactivity (NDO)

March 30, 2021

• Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients

March 31, 2021

• FDA Approves Sarclisa (isatuximab-irfc) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

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

• FDA Approves Trodelvy, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

April 12, 2021

• FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

April 13, 2021

• U.S. FDA Grants Accelerated Approval to Trodelvy for the Treatment of Metastatic Urothelial Cancer

April 16, 2021

• FDA Approves Opdivo (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma Regardless of PD-L1 Expression Status

April 19, 2021

• U.S. FDA Approves ALK's Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis

April 30, 2021

• Farxiga Approved in the US for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type-2 Diabetes

May 1, 2021

• Chiesi Global Rare Diseases Announces FDA Approval of Ferriprox (deferiprone) for Treatment of Transfusional Iron Overload due to Sickle Cell Disease

May 5, 2021

• FDA Approves Merck’s Keytruda (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

May 6, 2021

• Injectafer (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia

May 20, 2021

• FDA Approves Opdivo (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy

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

• Kedrion and Kamada Announce FDA Approval of KedRAB Label Update, Confirming Safety and Effectiveness in Children

June 7, 2021

• Alexion Announces FDA Approval of Ultomiris (ravulizumab-cwvz) for Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)

June 9, 2021

• Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations

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

• FDA Approves Blueprint Medicines' Ayvakit (avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis

June 21, 2021

• FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children

July 1, 2021

• Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis

July 6, 2021

• FDA Approves Expanded Indication for Merck’s Keytruda (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

July 9, 2021

• U.S. FDA Grants Regular Approval and Expands Indication for Padcev (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

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

• FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

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

• Shingrix Approved in the US for Prevention of Shingles in Immunocompromised Adults

July 27, 2021

• FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery

July 28, 2021

• FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

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

• Uptravi (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)

August 11, 2021

• FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC)

August 12, 2021

• Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults

August 16, 2021

• FDA Approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for Use in Insulin Pumps

August 17, 2021

• GSK Receives FDA Accelerated Approval for Jemperli (dostarlimab-gxly) for Adult Patients with Mismatch Repair-Deficient (dMMR) Recurrent or Advanced Solid Tumors

August 18, 2021

• FDA Approves Jardiance (empagliflozin) to Treat Adults Living with Heart Failure with Reduced Ejection Fraction

August 20, 2021

• U.S. Food and Drug Administration Approves Opdivo (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma

August 23, 2021

• Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke Kit for the Treatment of Severe Hypoglycemia

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

• UCB Announces Briviact (brivaracetam) Now FDA-Approved to Treat Partial-Onset Seizures in Pediatric Patients One Month of Age and Older

September 1, 2021

• U.S. FDA Grants Brukinsa (zanubrutinib) Approval in Waldenström’s Macroglobulinemia

September 15, 2021

• U.S. FDA Grants Brukinsa (zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma

September 17, 2021

• Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

September 22, 2021

• Incyte Announces FDA Approval of Jakafi (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)

September 24, 2021

• FDA Approves Repatha (evolocumab) In Pediatric Patients Age 10 And Older With Heterozygous Familial Hypercholesterolemia

October 1, 2021

• U.S. FDA Approves Kite’s Tecartus as the First and Only CAR-T for Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

October 11, 2021

• Ocular Therapeutix Announces FDA Approval of sNDA for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for Intracanalicular Use for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

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

• U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations

October 20, 2021

• FDA Expands Approval of Dupixent (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma

November 5, 2021

• Tris Pharma Announces FDA Approval of Dyanavel XR (amphetamine) Once-Daily Extended-Release Oral Tablets, CII, for ADHD

November 18, 2021

• FDA Approves Merck’s Keytruda (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

December 9, 2021

• Heron Therapeutics Announces FDA Approval of an Indication Expansion for Zynrelef for Postoperative Pain Management

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

• U.S. Food and Drug Administration Approves Orencia (abatacept) in Combination with a Calcineurin Inhibitor and Methotrexate for the Prevention of Acute Graft Versus Host Disease (aGvHD)

December 16, 2021

• Injectafer (ferric carboxymaltose injection) Receives FDA Approval for the Treatment of Pediatric Patients with Iron Deficiency Anemia

December 17, 2021

• U.S. FDA Approves Supplemental New Drug Application for Expanded Indication of Oxbryta (voxelotor) for Children as Young as 4 Years of Age with Sickle Cell Disease

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

December 22, 2021

• Novartis Cosentyx Receives FDA Approval for the Treatment of Children and Adolescents with Enthesitis-Related Arthritis and Psoriatic Arthritis