Neelam Sharma MS; Lavanya Kundurthy BE; and Hemant N. Joshi, Ph.D., MBA#- Tara Innovations LLC, # [email protected]; www.tara-marketing.com
This quarterly review on New Drug Applications contains data for applications approved during the second quarter of 2023, which includes New Molecular Entities (NMEs) and new biologics. A total of 39 applications were approved by the FDA during these three months.
The NDAs approved during the second quarter of 2023 have been divided into seven different dosage forms. Following are the percentages of those dosage forms – Injection (48.7%), Tablets (15.0%), Capsules (7.7%), Oral liquids - suspension/solution (7.7%), Oral films (5.1%), Metered dose (5.1%) and other (10.1%, oral granules, nasal spray, ophthalmic solution). Recently, there has been more focus on injectable formulations. Following are the submission classifications: BLA (17.5%), Type 1 (New molecular entity, 20.0%), Type 3 (New dosage form, 20.0%), Type 4 (New combination, 10.0%), and Type 5 (New formulation or manufacturer, 32.5%).
XACDURO® (sulbactam for injection; durlobactam for injection), co packaged for intravenous use is a combination of sulbactam, a beta lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
QALSODY™ (tofersen) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY.
Fabry disease is a rare inherited disease caused by the deficiency of an enzyme called alpha-galactosidase A that normally breaks down a fatty substance called globotriaosylceramide (Gb3). It can have varied symptoms such as pain in the hands, feet and specific skin rashes. ELFABRIO is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease. The recommended dosage is 1 mg/kg every two weeks administered as an infusion.
MIEBO is a prescription eye drop used to treat the signs and symptoms of dry eye disease. It works by preventing excessive tear evaporation. It contains perfluorohexyloctane, a semifluorinated alkane that works to stabilize the tear film on the surface of the eye, stopping the tears from evaporating and preventing drying of the eyes.
LITFULO (ritlecitinib) is an oral, once-daily prescription treatment for severe alopecia areata in adults and adolescents aged 12 and older. Alopecia areata is an autoimmune disease characterized by patchy hair loss, usually on the scalp but occasionally on the face (eyebrows, eyelashes, beard) and other body areas. It is caused by the body’s immune system attacking healthy hair follicles, which causes the hair to fall out.
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