This quarterly review of New Drug Applications contains data for applications approved during the first quarter of 2024, which includes New Molecular Entities (NMEs) and new biologics. A total of 28 applications were approved by the FDA during these three months.
The NDAs approved during the first quarter of 2024 have been divided into nine different dosage forms. Following are the percentages of those dosage forms – injection (46.4%), tablets (25%), oral suspension (7.1%), topical gel (7.1%) and capsules, oral solution, gas, ophthalmic, and tablet for suspension (3.6% each). Following are the submission classifications: BLA (23.3%), Type 1 (New Molecular Entity, 20.0%), Type 2 ( New Active Ingredient, 6.7%), Type 3 (New Dosage Form, 20.0%), Type 4 (New Combination, 13.3%), and Type 5 (New Formulation or Manufacturer, 16.7%).
Topical gel Zelsuvmi has been approved by the FDA for use in patients 1 year and older with molluscum contagiosum. Zelsuvmi (brazier gel 10.3%) releases nitric oxide upon application which has an antimicrobial effect. It is the first prescription treatment indicated for the viral infection that mostly affects children.
EOHILIA is a corticosteroid indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).
Aprocitentan, sold under the brand name Tryvio, is a medication used for the treatment of hypertension (high blood pressure). It is an endothelin receptor antagonist active at both endothelin A and endothelin B receptors.
Winrevair is a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH). Following its approval in 2024, the list price of Winrevair as a single-vial and double-vial kit was announced at $14,000 per vial, with an estimated annual cost of $240,000 a year. It was determined that Winrevair would be cost-effective for treating PAH if priced between $18,700 and $36,200 annually.
Exblifep contains a combination of Cefepime HCl and Enmetazobactam. Cefepime is a cephalosporin antibacterial. Enmetazobactam is a beta-lactamase inhibitor. Enmetazobactam was first invented in India by Orchid Pharma and then out-licensed to Allecra Therapeutics (Patent #7687488B2).
Author Details
Neelam Sharma MS; Lavanya Kundurthy BE; and Hemant N. Joshi, PhD, MBA# - Tara Innovations LLC, # [email protected], www.tara-marketing.com
Publication Details
This article appeared in Pharmaceutical Outsourcing: Vol. 25, No. 2Apr/May/Jun 2024Pages: 35-37