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
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)
- 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)
- 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
- 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)
- 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)
- 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)
- 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)
- 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)