This quarterly review of New Drug Applications contains data for applications approved during the second quarter of 2024, which includes new molecular entities (NMEs) and new biologics. A total of 37 applications were approved by the FDA during these three months.
The NDAs approved during the second quarter of 2024 have been divided into 10 different dosage forms. Following are the percentages of those dosage forms – injection (51.4%), tablets (16.2%), capsules (8.1%), oral solution 5.4%, oral suspension 5.4%, and 2.7% each of buccal films, nasal spray, oral granules, topical gel and ophthalmic. Recently, there has been more focus on injectable formulations. Following are the submission classifications: BLA (32.4%), Type 1 (New molecular entity, 18.9%), Type 2 (New active ingredient – 5.4%), Type 3 (New dosage form, 32.4%), and Type 5 (New formulation or manufacturer, 10.8%). There has been an increased focus recently on BLA products.
MDELLTRA™ (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. This is the first and only T-Cell engager therapy. It has received accelerated approval based on the encouraging response rate and duration of response observed in clinical studies.
ONYDA XR received FDA approval for the treatment of ADHD as a monotherapy or as an adjuvant therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older. It is a once-daily extended-release oral suspension with night-time dosing. It is the first and only liquid non-stimulant ADHD medication.
SOFDRA is a drug product developed by Botanix. It contains sofpironium bromide, which is used to treat hyperhidrosis (excessive sweating). It is an anticholinergic agent, which reduces sweating by inhibiting M3 muscarinic receptors in eccrine glands (sweat glands).
ZEVTERA contains ceftobiprole, a fifth-generation cephalosporin antibacterial agent used for the treatment of hospital and community-acquired pneumonia. Zevtera has been approved for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB); adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP).
FDA granted an accelerated approval to OJEMDA, which contains Tovorafenib. It can be used in patients six months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
LUMISIGHT (pegulicianine) is a fluorescent imaging drug that is administered in the form of an intravenous injection before surgery. It can be used in adults with breast cancer to assist in the intraoperative detection of cancerous tissue within the resection cavity following the removal of the primary specimen during lumpectomy surgery.
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.3 July/Aug/Sept 2024Pages: 36-38