Original New Drug Application Approvals by US FDA (16 - 31 December 2021)

06 Jan 2022
Original New Drug Application Approvals by US FDA (16 - 31 December 2021)
New drug applications approved by US FDA as of 16-31 December 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

DARTISLA ODT
  • Active Ingredient(s): Glycopyrrolate
  • Strength: 1.7MG
  • Dosage Form(s) / Route(s): Tablet, Orally Disintegrating; Oral
  • Company: Edenbridge Pharms
  • Approval Date: 16 December 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
  • Approved Label16 December 2021 (PDF)
LANREOTIDE ACETATE
  • Active Ingredient(s): Lanreotide Acetate
  • Strength: EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML); EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML); EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
  • Dosage Form(s) / Route(s): Solution; Subcutaneous
  • Company:  Invagen Pharms
  • Approval Date: 17 December 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • The long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
    • The treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
  • Approved Label17 December 2021 (PDF)
OXBRYTA
  • Active Ingredient(s): Voxelotor
  • Strength: 300MG; 500MG
  • Dosage Form(s) / Route(s): Tablet, For Suspension; Oral; Table
  • Company: Global Blood Theraps
  • Approval Date: 17 December 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older. 
  • Approved Label17 December 2021 (PDF)
VYVGART
  • Active Ingredient(s): Efgartigimod Alfa
  • Strength: 400MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Argenx Bv
  • Approval Date: 17 December 2021
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. 
  • Approved Label17 December 2021 (PDF)
REZVOGLAR
  • Active Ingredient(s): Insulin Glargine-aglr
  • Strength: 3ML(100UNITS/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Eli Lilly Co
  • Approval Date: 17 December 2021
  • Submission Classification: Not available
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
  • Approved Label17 December 2021 (PDF)
YUSIMRY
  • Active Ingredient(s): Adalimumab-aqvh 
  • Strength: 40MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Coherus Biosciences Inc
  • Approval Date: 17 December 2021
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
    • Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
    • Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
    • Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
    • Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
    • Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
    • Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.  
  • Approved Label17 December 2021 (PDF)
TEZSPIRE
  • Active Ingredient(s): Tezepelumab-ekko
  • Strength: 210MG/1.91ML(110MG/ML)
  • Dosage Form(s) / Route(s): Solution; Subcutaneous
  • Company: Astrazeneca Ab
  • Approval Date: 17 December 2021
  • Submission Classification: Not available
  • Indication(s): Indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
  • Approved Label17 December 2021 (PDF)
APRETUDE
  • Active Ingredient(s): Cabotegravir
  • Strength: 600MG/3ML (200MG/ML)
  • Dosage Form(s) / Route(s): For Suspension, Extended Release; Intramuscular
  • Company: Viiv Hlthcare
  • Approval Date: 20 December 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the back pain, and upper respiratory tract infection. risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in To report SUSPECTED ADVERSE REACTIONS, contact ViiV with oral cabotegravir) for HIV-1 PrEP.
  • Approved Label20 December 2021 (PDF)
XARELTO
  • Active Ingredient(s): Rivaroxaban
  • Strength: 1MG/ML
  • Dosage Form(s) / Route(s): Suspension; Oral
  • Company: Janssen Pharms
  • Approval Date: 20 December 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation
    • for treatment of deep vein thrombosis (DVT)
    • for treatment of pulmonary embolism (PE)
    • for reduction in the risk of recurrence of DVT or PE
    • for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
    • for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients
    • to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)
    • to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD
    • for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years
    • for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure 
  • Approved Label20 December 2021 (PDF)
LEQVIO
  • Active Ingredient(s): Inclisiran
  • Strength: 284MG/1.5ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Novartis Pharms Corp
  • Approval Date: 22 December 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C)
  • Approved Label: 22 December 2021 (PDF)
ADBRY
  • Active Ingredient(s): Tralokinumab
  • Strength: 150MG/ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Leo Pharma As
  • Approval Date: 27 December 2021
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available
CABAZITAXEL
  • Active Ingredient(s): Cabazitaxel
  • Strength: 20MG/ML(60MG/3ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Accord Hlthcare Inc
  • Approval Date: 29 December 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available
RECORLEV
  • Active Ingredient(s): Levoketoconazole
  • Strength: 150MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Strongbridge Dublin Ltd
  • Approval Date: 30 December 2021
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Not available
  • Approved Label: Not available

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