This quarterly review on New Drug Applications contains data for applications approved for the first time during April-June of 2020, which includes New Molecular Entities (NMEs) and new biologics. A total of 43 applications were approved by FDA during these three months.
Following are the percentages of various dosage forms in this quarter-18.6% tablets, 7% oral liquids, 32.6 % injectables, 14% capsules, 7% gas inhalation, 4.7% topical, and 16.3% others. Other dosage forms include pyelocaliceal powder, sublingual film, nasal spray and vaginal formulations. Based on the submission classification, the NDAs can be divided as follows: new molecular entity (Type 1) – 30.2%, new active ingredient (Type 2) – 2.3%, new dosage form (Type 3) – 18.6%, new combination (Type 4) – 4.6%, new formulation or manufacturer (Type 5) – 16.3%, new indication consolidated with original NDA – 2.3%, new indication, non-consolidated with original NDA – 2.3%, Biological License Application (BLA) – 16.3% and others – 7%.
During this quarter, FDA approved Seattle Genetics’ TUKYSA (Tucatinib) and Desiphera Pharms’ INLOCK (Ripretinib) applications under the Real-Time Oncology Review (RTOR) pilot program. The Oncology Center of Excellence RTOR pilot program is a more streamlined and efficient way to review applications. This program focuses on early submission of data that are the most relevant to assessing the product’s safety and effectiveness. The FDA will have the flexibility to review the data before the information is formally submitted to FDA. This early engagement may improve the quality of the NDA submission and FDA’s evaluation of the application. Acceptance into the RTOR pilot program does not guarantee or influence approvability of the application.
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Evoke Pharma obtained FDA approval for GIMOTI (metoclopramide) nasal spray. GIMOTI is the first and only nasally administered product for acute and recurrent diabetic gastroparesis. Gastroparesis is a disease that blocks or slows the movement of the contents of the stomach to the small intestine. Oral drug administration is often compromised. This novel nasal formulation provides an alternative mean of delivering metoclopramide in patients with delayed gastric emptying and/or frequent vomiting.
In May 2020, FDA approved ORIAHNN™ (Elagolix, estradiol, and norethindrone acetate capsules; Elagolix capsules). It is the first non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. It is a non-invasive treatment that not only reduces the amount of bleeding but may also help another side effect of fibroids in some women: iron-deficiency anemia.
Two products received the orphan drug status in this period. They are – Ferriprox, Deferiprone tablets by Chiesi and Tazverik, Tazemetostat HBr by Epizyme, Inc.