New Indications & Dosage Forms for Existing Drugs

Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Injection

Patient Population Altered: June 17, 2022
Date of Original Approval: July 16, 2021

Vaxneuvance (pneumococcal 15-valent conjugate vaccine) is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.

• U.S. FDA Approves Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children
• Vaxneuvance approval history

Imcivree (setmelanotide) Injection

New Indication Approved: June 16, 2022
Date of Original Approval: November 25, 2020

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency; or Bardet-Biedl syndrome.

• Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Use in Patients with Bardet-Biedl Syndrome
• Imcivree approval history

Skyrizi (risankizumab-rzaa) Injection

New Indication Approved: June 16, 2022
Date of Original Approval: April 23, 2019

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease.

• Skyrizi (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults
• Skyrizi approval history

Olumiant (baricitinib) Tablets

New Indication Approved: June 13, 2022
Date of Original Approval: May 31, 2018

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, COVID-19, and alopecia areata.

• FDA Approves Lilly and Incyte's Olumiant (baricitinib) as First and Only Systemic Medicine for Adults with Severe Alopecia Areata
• Olumiant approval history

Dupixent (dupilumab) Injection

Patient Population Altered: June 7, 2022
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and eosinophilic esophagitis.

• FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
• Dupixent approval history

CellCept (mycophenolate mofetil) Tablets, Capsules, Oral Suspension, Injection

Patient Population Altered: June 6, 2022
Date of Original Approval: May 3, 1995

CellCept (mycophenolate mofetil) is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

• FDA Approves Expansion of CellCept (mycophenolate mofetil) Indication to Pediatric Heart Transplant and Pediatric Liver Transplant Populations
• CellCept approval history

Riabni (rituximab-arrx) Injection

New Indication Approved: June 3, 2022
Date of Original Approval: December 17, 2020

Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

• FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan (rituximab), for Adults with Moderate to Severe Rheumatoid Arthritis
• Riabni approval history

Opdivo (nivolumab) Injection

New Indication Approved: May 27, 2022
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.

• U.S. Food and Drug Administration Approves Two Opdivo (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
• Opdivo approval history

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion

New Indication Approved: May 27, 2022
Date of Original Approval: August 30, 2017

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of B-cell acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and follicular lymphoma (FL).

• FDA Approves Novartis Kymriah CAR-T Cell Therapy for Adult Patients with Relapsed or Refractory Follicular Lymphoma
• Kymriah approval history

Evrysdi (risdiplam) for Oral Solution

Patient Population Altered: May 27, 2022
Date of Original Approval: August 7, 2020

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

• FDA Approves Label Extension for Evrysdi for Infants with Spinal Muscular Atrophy Under 2 Months Old
• Evrysdi approval history

Beovu (brolucizumab-dbll) Injection

New Indication Approved: May 27, 2022
Date of Original Approval: October 7, 2019

Beovu (brolucizumab-dbll) is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).

• Novartis Announces FDA Approval of Beovu for the Treatment of Diabetic Macular Edema
• Beovu approval history

Tibsovo (ivosidenib) Tablets

New Indication Approved: May 25, 2022
Date of Original Approval: July 20, 2018

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor used in the treatment of patients with IDH1-mutated acute myeloid leukemia (AML) and IDH1-mutated cholangiocarcinoma.

• Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia
• Tibsovo approval history

Tyvaso (treprostinil) Inhalation Solution

New Formulation Approved: May 23, 2022
Date of Original Approval: July 30, 2009

Tyvaso (treprostinil) is a prostacyclin mimetic used for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

• United Therapeutics Announces FDA Approval of Tyvaso DPI
• Tyvaso approval history

Dupixent (dupilumab) Injection

New Indication Approved: May 20, 2022
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and eosinophilic esophagitis.

• FDA Approves Dupixent (dupilumab) as First Treatment for Adults and Children Aged 12 and Older with Eosinophilic Esophagitis
• Dupixent approval history

TPOXX (tecovirimat) Capsules and Injection

New Formulation Approved: May 18, 2022
Date of Original Approval: July 13, 2018

TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease.

• SIGA Receives Approval from the FDA for Intravenous (IV) Formulation of TPOXX (tecovirimat)
• TPOXX approval history

Olumiant (baricitinib) Tablets

New Indication Approved: May 10, 2022
Date of Original Approval: May 31, 2018

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, COVID-19, and alopecia areata.

• FDA Approves Olumiant (baricitinib) Treatment for COVID-19 in Certain Hospitalized Adults
• Olumiant approval history

Enhertu (fam-trastuzumab deruxtecan-nxki) Injection

New Indication Approved: May 4, 2022
Date of Original Approval: December 20, 2019

Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction adenocarcinoma.

• Enhertu Approved in the US for Patients with HER2-Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
• Enhertu approval history

Qelbree (viloxazine hydrochloride) Extended Release Capsules

Patient Population Altered: April 29, 2022
Date of Original Approval: April 2, 2021

Qelbree (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) for the treatment of attention deficit hyperactivity disorder (ADHD) in in adults and pediatric patients 6 years and older.

• Supernus Announces FDA Approval of Qelbree for the Treatment of ADHD in Adults
• Qelbree approval history

Rinvoq (upadacitinib) Extended-Release Tablets

New Indication Approved: April 29, 2022
Date of Original Approval: August 16, 2019

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.

• Rinvoq (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis
• Rinvoq approval history

Ultomiris (ravulizumab-cwvz) Injection

New Indication Approved: April 27, 2022
Date of Original Approval: December 21, 2018

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor used for the treatment of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, and generalized myasthenia gravis.

• Ultomiris Approved in the US for Adults with Generalised Myasthenia Gravis
• Ultomiris approval history

Caplyta (lumateperone) Capsules

New Formulation Approved: April 26, 2022
Date of Original Approval: December 20, 2019

Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.

• Intra-Cellular Therapies Announces FDA Approval of New Dosage Strengths for Caplyta (lumateperone) for Specific Patient Populations
• Caplyta approval history

Veklury (remdesivir) Injection

Patient Population Altered: April 25, 2022
Date of Original Approval: October 22, 2020

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19.

• Veklury (remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19
• Veklury approval history

Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion

New Indication Approved: April 1, 2022
Date of Original Approval: October 18, 2017

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) used for the treatment of large B-cell lymphoma and follicular lymphoma.

• Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)
• Yescarta approval history

Triumeq (abacavir, dolutegravir and lamivudine) Tablets

New Dosage Form Approved: March 30, 2022
Date of Original Approval: August 22, 2014

Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.

• ViiV Healthcare Announces US FDA Approval of Triumeq PD, the First Dispersible Single Tablet Regimen Containing Dolutegravir, a Once-Daily Treatment for Children Living with HIV
• Triumeq approval history

Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)

Patient Population Altered: March 29, 2022
Date of Original Approval: January 21, 2021

Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.

• ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Virologically Suppressed Adolescents Living with HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg
• Cabenuva approval history

Ozempic (semaglutide) Injection

New Dosage Regimen: March 28, 2022
Date of Original Approval: December 5, 2017

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog indicated:

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

• Novo Nordisk Receives FDA Approval of Higher-Dose Ozempic 2 mg Providing Increased Glycemic Control for Adults with Type 2 Diabetes
• Ozempic approval history

Fintepla (fenfluramine) Oral Solution

New Indication Approved: March 25, 2022
Date of Original Approval: June 25, 2020

Fintepla (fenfluramine) is an amphetamine derivative indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

• Fintepla (fenfluramine) Oral Solution Now FDA Approved for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS)
• Fintepla approval history

Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)

Labeling Revision Approved: March 23, 2022
Date of Original Approval: January 21, 2021

Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.

• ViiV Healthcare Announces Label Update for its Long-Acting HIV Treatment, Cabenuva (cabotegravir, rilpivirine), to be Initiated With or Without an Oral Lead-In Period
• Cabenuva approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: March 21, 2022
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.

• FDA Approves Merck’s Keytruda (pembrolizumab) for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation
• Keytruda approval history

Rinvoq (upadacitinib) Extended-Release Tablets

New Indication Approved: March 16, 2022
Date of Original Approval: August 16, 2019

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.

• Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
• Rinvoq approval history

Lynparza (olaparib) Tablets

New Indication Approved: March 11, 2022
Date of Original Approval: December 19, 2014

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

• Lynparza Approved in the US as Adjuvant Treatment for Patients with Germline BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer
• Lynparza approval history

Opdivo (nivolumab) Injection

New Indication Approved: March 4, 2022
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.

• U.S. Food and Drug Administration Approves Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer
• Opdivo approval history

Jardiance (empagliflozin) Tablets

New Indication Approved: February 24, 2022
Date of Original Approval: August 1, 2014

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of type 2 diabetes, to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease, and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.

• US FDA Approves Jardiance (empagliflozin) to Treat Adults with Heart Failure Regardless of Left Ventricular Ejection Fraction
• Jardiance approval history

Takhzyro (lanadelumab-flyo) Injection

New Formulation Approved: February 9, 2022
Date of Original Approval: August 23, 2018

Takhzyro (lanadelumab-flyo) is a plasma kallikrein inhibitor (monoclonal antibody) for the prevention of angioedema attacks in patients with hereditary angioedema.

• Takeda Receives U.S. FDA Approval for Prefilled Syringe Presentation of Takhzyro (lanadelumab-flyo) for Use as a Preventive Treatment for Hereditary Angioedema Attacks
• Takhzyro approval history

Juvederm (dermal filler)

New Indication Approved: February 8, 2022
Date of Original Approval: June 2, 2006

Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

• FDA Approves Juvéderm Volbella XC For Undereye Hollows
• Juvederm approval history

Vonvendi (von willebrand factor (recombinant)) for Injection

New Indication Approved: January 31, 2022
Date of Original Approval: December 8, 2015

Vonvendi (von Willebrand factor (recombinant)) is a recombinant von Willebrand factor for the treatment of von Willebrand disease(VWD).

• FDA Approves Prophylactic Treatment with Vonvendi [von Willebrand Factor (Recombinant)] for Adult Patients Living with Severe Type 3 von Willebrand Disease (VWD)
• Vonvendi approval history

Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion

Labeling Revision Approved: January 31, 2022
Date of Original Approval: October 18, 2017

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) used for the treatment of large B-cell lymphoma and follicular lymphoma.

• U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta Showing Prophylactic Steroid Use Improves Management of Cytokine Release Syndrome
• Yescarta approval history

Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)

New Dosage Regimen: January 31, 2022
Date of Original Approval: January 21, 2021

Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.

• ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Use Every Two Months, Expanding the Label of the First and Only Complete Long-Acting HIV Treatment
• Cabenuva approval history

Solosec (secnidazole) Oral Granules

Patient Population Altered: January 26, 2022
Date of Original Approval: September 15, 2017

Solosec (secnidazole) is a nitroimidazole antimicrobial for use as a single-dose oral therapy in the treatment of bacterial vaginosis (BV) and trichomoniasis.

• Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) in Adolescents for both the Treatment of Bacterial Vaginosis in Females and Trichomoniasis
• Solosec approval history

Nucala (mepolizumab) Injection

New Dosage Regimen: January 24, 2022
Date of Original Approval: November 4, 2015

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) used for the treatment of with severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and hypereosinophilic syndrome (HES).

• FDA Approves Nucala (mepolizumab) 40 mg Prefilled Syringe for Children with Severe Eosinophilic Asthma
• Nucala approval history

Veklury (remdesivir) Injection

New Indication Approved: January 21, 2022
Date of Original Approval: October 22, 2020

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19.

• FDA Approves Veklury (remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
• Veklury approval history

Skyrizi (risankizumab-rzaa) Injection

New Indication Approved: January 21, 2022
Date of Original Approval: April 23, 2019

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease.

• U.S. FDA Approves Second Indication for Skyrizi (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis
• Skyrizi approval history

Rinvoq (upadacitinib) Extended-Release Tablets

New Indication Approved: January 14, 2022
Date of Original Approval: August 16, 2019

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.

• U.S. FDA Approves Rinvoq (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis
• Rinvoq approval history

Cosentyx (secukinumab) Injection

Patient Population Altered: December 22, 2021
Date of Original Approval: January 21, 2015

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.

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

Xarelto (rivaroxaban) Tablets and Oral Suspension

Patient Population Altered: December 20, 2021
Date of Original Approval: July 1, 2011

Xarelto (rivaroxaban) is a factor Xa inhibitor used for the treatment and prevention of blood clots that are related to certain conditions involving the heart and blood vessels.

• FDA Approves Two New Indications for Xarelto (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
• Xarelto approval history

Otezla (apremilast) Tablets

New Indication Approved: December 20, 2021
Date of Original Approval: March 21, 2014

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s Disease.

• FDA Approves Otezla (apremilast) for the Treatment of Adult Patients with Plaque Psoriasis, Regardless of Severity Level
• Otezla approval history

Oxbryta (voxelotor) Tablets

Patient Population Altered: December 17, 2021
Date of Original Approval: November 25, 2019

Oxbryta (voxelotor) is an oral, HbS (sickle hemoglobin) polymerization inhibitor for the treatment of patients with sickle cell disease (SCD).

• 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
• Oxbryta approval history

Caplyta (lumateperone) Capsules

New Indication Approved: December 17, 2021
Date of Original Approval: December 20, 2019

Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.

• Intra-Cellular Therapies Announces U.S. FDA Approval of Caplyta (lumateperone) for the Treatment of Bipolar Depression in Adults
• Caplyta approval history

Orencia (abatacept) Injection

New Indication Approved: December 15, 2021
Date of Original Approval: December 23, 2005

Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and the prophylaxis of acute graft versus host disease (aGVHD).

• 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)
• Orencia approval history

Xeljanz (tofacitinib) Tablets and Oral Solution

New Indication Approved: December 14, 2021
Date of Original Approval: November 6, 2012

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.

• U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Ankylosing Spondylitis
• Xeljanz approval history