Original New Drug Application Approvals by US FDA (16-30 September 2024) | Multidisciplinary

New drug applications approved by US FDA as of 16-30 September 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.

MIPLYFFA

Active Ingredient(s): Arimoclomol Citrate
Strength: EQ 47MG BASE; EQ 62MG BASE; EQ 93MG BASE; EQ 124MG BASE
Dosage Form(s) / Route(s): Capsule;oral
Company: Zevra Denmark
Approval Date: 20 September 2024
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older.
Approved Label: 20 September 2024 (PDF)

AQNEURSA

Active Ingredient(s): Levacetylleucine
Strength: 1GM/PACKET
Dosage Form(s) / Route(s): Suspension;oral
Company: Intrabio Inc
Approval Date: 24 September 2024
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.
Approved Label: 24 September 2024 (PDF)

COBENFY

Active Ingredient(s): Xanomeline Tartrate;trospium Chloride
Strength: 20MG;EQ 50MG BASE; 20MG;EQ 100MG BASE; 30MG;EQ 125MG BASE
Dosage Form(s) / Route(s): Capsule;oral
Company: BRISTOL-MYERS
Approval Date: 26 September 2024
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of schizophrenia in adults.
Approved Label: 26 September 2024 (PDF)

BYNFEZIA PEN

Active Ingredient(s): Octreotide Acetate
Strength: 7MG/2.8ML (2.5MG/ML)
Dosage Form(s) / Route(s): Solution;subcutaneous
Company: Sun Pharm
Approval Date: 27 September 2024
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated:

Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors.

Approved Label: 27 September 2024 (PDF)

FLYRCADO

Active Ingredient(s): Flurpiridaz F 18
Strength: 5-55mCi/ML
Dosage Form(s) / Route(s): Solution;intravenous
Company: Ge Healthcare
Approval Date: 27 September 2024
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.
Approved Label: 27 September 2024 (PDF)

OTULFI

Active Ingredient(s): Ustekinumab-aauz
Strength: 45MG; 90MG
Dosage Form(s) / Route(s): Injectable;injection
Company: Fresenius Kabi Usa
Approval Date: 27 September 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: 27 September 2024 (PDF)