Original New Drug Application Approvals by US FDA (16-31 May 2023)

01 Jun 2023
Original New Drug Application Approvals by US FDA (16-31 May 2023)
New drug applications approved by US FDA as of 16-31 May 2023 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.

MIEBO
  • Active Ingredient(s): Perfluorohexyloctane
  • Strength: 1.338GM/ML
  • Dosage Form(s) / Route(s): Solution/drops;ophthalmic
  • Company: Bausch And Lomb Inc
  • Approval Date: 18 May 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for treatment of the signs and symptoms of dry eye disease.
  • Approved Label:  18 May (PDF)
EPKINLY
  • Active Ingredient(s): Epcoritamab-bysp
  • Strength: 4MG/0.8ML, 48MG/0.8ML
  • Dosage Form(s) / Route(s): Injectable;subcutaneous
  • Company: Genmab Us, Inc.
  • Approval Date: 19 May 2023
  • Submission Classification: N/A
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

    This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label:  19 May (PDF)
PEMETREXED
  • Active Ingredient(s): Pemetrexed
  • Strength: 100MG/10ML, 500MG/50ML, 1000MG/100ML
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Shilpa Medicare Ltd
  • Approval Date: 22 May 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous nonsmall cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
    • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
    • as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
    • as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.

      • Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.
    • initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
  • Approved Label:  22 May (PDF)
OPVEE
  • Active Ingredient(s): Nalmefene
  • Strength: 2.7MG
  • Dosage Form(s) / Route(s): Spray;nasal
  • Company: Opiant Pharmaceuticals Inc
  • Approval Date: 22 May 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.

    OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

    OPVEE nasal spray is not a substitute for emergency medical care.
  • Approved Label:  22 May (PDF)
BRIXADI
  • Active Ingredient(s): Buprenorphine
  • Strength: 8MG/0.16ML (50MG/ML), 16MG/0.32ML (50MG/ML), 24MG/0.48ML (50MG/ML), 32MG/0.64ML (50MG/ML), 64MG/0.18ML (356MG/ML), 96MG/0.27ML (356MG/ML), 128MG/0.36ML (356MG/ML)
  • Dosage Form(s) / Route(s): Solution, Extended Release;subcutaneous
  • Company: Braeburn
  • Approval Date: 23 May 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

    BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support
  • Approved Label:  23 May (PDF)
XACDURO (COPACKAGED)
  • Active Ingredient(s): Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium
  • Strength: EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
  • Dosage Form(s) / Route(s): Powder;intravenous
  • Company: Entasis Therapeutics Inc
  • Approval Date: 23 May 2023
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

    Limitations of Use:
    XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumanniicalcoaceticus complex.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  23 May (PDF)
YUFLYMA
  • Active Ingredient(s): Adalimumab-aaty
  • Strength: 40MG/0.4ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Celltrion
  • Approval Date: 23 May 2023
  • Submission Classification: N/A
  • 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.
    • Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients.
  • Approved Label:  23 May (PDF)
POSLUMA
  • Active Ingredient(s): Flotufolastat F-18
  • Strength: 296MBQ/ML
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Blue Earth Diagnostics Ltd.
  • Approval Date: 25 May 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
    • with suspected metastasis who are candidates for initial definitive therapy
    • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
  • Approved Label:  25 May (PDF)
PAXLOVID (COPACKAGED)
  • Active Ingredient(s): Nirmatrelvir, Ritonavir
  • Strength: 150MG;100MG, 300MG;100MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Pfizer Inc
  • Approval Date: 25 May 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

    Limitations of Use
    PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
  • Approved Label:  25 May (PDF)
INPEFA
  • Active Ingredient(s): Sotagliflozin
  • Strength: 200MG, 400MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Lexicon Pharmaceuticals Inc
  • Approval Date: 26 May 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
    • heart failure or
    • type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors
  • Approved Label:  26 May (PDF)
VEVYE
  • Active Ingredient(s): Cyclosporine
  • Strength: 0.1%
  • Dosage Form(s) / Route(s): Solution;ophthalmic
  • Company: Novaliq Gmbh
  • Approval Date: 30 May 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of the signs and symptoms of dry eye disease.
  • Approved Label:  30 May (PDF)