Original New Drug Application Approvals by US FDA (16 - 31 May 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 Label: 17 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 Label: 21 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)