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

02 Jun 2021
New drug applications approved by US FDA as of 16-31 May 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.

LEVOTHYROXINE SODIUM
  • Active Ingredient(s): Levothyroxine Sodium
  • Strength: 100MCG/ML
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Custopharm Inc
  • Approval Date: 17 May 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of myxedema coma.
  • Approved Label17 May 2021 (PDF)
RYBREVANT
  • Active Ingredient(s): Amivantamab-vmjw
  • Strength: 350MG/7ML(50MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Janssen Biotech
  • Approval Date: 21 May 2021
  • Submission Classification: Not available
  • Indication(s):  Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
  • Approved Label21 May 2021 (PDF)
CAMCEVI KIT
  • Active Ingredient(s): Leuprolide Mesylate
  • Strength: EQ 42 MG BASE
  • Dosage Form(s) / Route(s): Emulsion; Subcutaneous
  • Company: Forsee Pharmaceuticals Co., Ltd.
  • Approval Date: 25 May 2021
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Not available
  • Approved Label: Not available
PYLARIFY
  • Active Ingredient(s): Piflufolastat F 18
  • Strength: 2960MBQ/ML (1MCI/ML,80MCI/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Progenics Pharms Inc
  • Approval Date: 26 May 2021
  • 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 prostatespecific antigen (PSA) level.
  • Approved Label: 26 May 2021 (PDF)
MYFEMBREE
  • Active Ingredient(s): Relugolix; Estradiol; Norethindrone Acetate
  • Strength: 40MG;1MG;0.5MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Myovant Sciences
  • Approval Date: 26 May 2021
  • Submission Classification: Type 4 - New Combination
  • Indication(s):  indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
  • Approved Label: 26 May 2021 (PDF)
LYBALVI
  • Active Ingredient(s): Olanzapine; Samidorphan
  • Strength: 5MG,10MG; 10MG,10MG; 15MG,10MG; 20MG,10MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Alkermes Inc
  • Approval Date: 28 May 2021
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s):  indicated for the treatment of:
    • Schizophrenia in adults
    • Bipolar I disorder in adults
      • Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
      • Maintenance monotherapy treatment
  • Approved Label: 28 May 2021 (PDF)
TRUSELTIQ
  • Active Ingredient(s): Infigratinib
  • Strength: 25MG; 100MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: QED Therapeutics Inc
  • Approval Date: 28 May 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s):  Indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
  • Approved Label: 28 May 2021 (PDF)
LUMAKRAS
  • Active Ingredient(s): Sotorasib
  • Strength: 120MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Amgen Inc
  • Approval Date: 28 May 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s):  Indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
  • Approved Label: 28 May 2021 (PDF)
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