Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE; and Hemant N. Joshi, PhD, MBA: Tara Innovations LLC, [email protected]
This quarterly review on New Drug Applications (NDAs) contains data for applications approved for the first time during the third quarter of 2022, which includes New Molecular Entities (NMEs) and new biologics. A total 37 applications were approved by the FDA during these three months.
Interestingly, 24 were injectable (64.9%) formulations. Other dosage forms approved were – tablets and oral suspensions: four each (10.8%), ophthalmic gel and solution: two (5.4%), and capsules, topical and buccal film: one each (2.7%). The products can be divided based on submission classification – Type 1 and 3: six each (16.2%), Type 4: two (5.4%), Type 5: 13 (35.1%), Type 7: two (5.4%), Type 10: one (2.7%), BLA – seven (18.9%). Lumryz (Sodium oxybate) was termed as FT 218, which is a tentative approval. Lumryz has met all required quality, safety, and efficacy standards necessary for approval in the U.S. Final approval is pending disposition of U.S. Patent No. 8,731,963, which is listed in FDA’s Orange Book.
The following products received a priority review - Midazolam Hydrochloride (autoinjector), Auvelity (bupropion HCl; Dextromethorphan HBr), Imbruvica (Ibrutinib), Pedmark (sodium thiosulfate), Elucirem (gadopiclenol), Terlivaz (terlipressin acetate), Relyvrio (sodium phenylbutyrate; taurursodiol), and Lytgobi (futibatinib).
Xenpozyme is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Patients treated with Xenpozyme have experienced hypersensitivity reactions. Prior to Xenpozyme administration, one should consider pretreating with antihistamines, antipyretics, and/or corticosteroids.
Omlonti is a prescription eye drop used for the treatment of glaucoma and ocular hypertension. Omlonti is the first in a new class of drugs called relatively selective prostaglandin EP2 receptor agonists. It works to reduce elevated pressure in the eye by increasing the drainage of a fluid called aqueous humor.
Bludigo is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.
Vegzelma (bevacizumab-adcd) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Pedmark is a prescription medicine used to decrease the risk of hearing loss in children one month of age and older who are receiving cisplatin for solid tumors (cancer) that have not spread to other parts of the body.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!