Original New Drug Application Approvals by US FDA (1-15 October 2024)
22 Oct 2024
New drug applications approved by US FDA as of 1-15 October 2024 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.
PYRIDOSTIGMINE BROMIDE
PYRIDOSTIGMINE BROMIDE
- Active Ingredient(s): Pyridostigmine Bromide
- Strength: 105MG
- Dosage Form(s) / Route(s): Tablet, Extended Release;oral
- Company: Amneal
- Approval Date: 4 October 2024
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults.
- Protective garments, including a gas mask, and
- Immediate atropine and pralidoxime therapy at the first sign of nerve agent poisoning.
- Approved Label: 4 October 2024 (PDF)
- Pyridostigmine bromide is for use in conjunction with
- Active Ingredient(s): Inavolisib
- Strength: 3MG; 9MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Genentech Inc
- Approval Date: 10 October 2024
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
- Approved Label: 10 October 2024 (PDF)
- Active Ingredient(s): Ustekinumab-srlf
- Strength: 45MG/0.5ML; 90MG/ML; 130MG/26ML
- Dosage Form(s) / Route(s): Injectable;intravenous
- Company: Accord Biopharma Inc.
- Approval Date: 10 October 2024
- Submission Classification: NA
- Indication(s): Indicated for the treatment of:
- moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
- active psoriatic arthritis (PsA).
- moderately to severely active Crohn’s disease (CD).
- moderately to severely active ulcerative colitis.
- moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
- active psoriatic arthritis (PsA).
- Approved Label: 10 October 2024 (PDF)
- Adult patients with:
- Pediatric patients 6 years and older with:
- Active Ingredient(s): Marstacimab-hncq
- Strength: 300MG
- Dosage Form(s) / Route(s): Injectable;subcutaneous
- Company: Pfizer Inc
- Approval Date: 11 October 2024
- Submission Classification: NA
- Indication(s): Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
- hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
- hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.
- Approved Label: 11 October 2024 (PDF)