This quarterly review on new drug applications contains data for applications approved for the first time during the fourth quarter of 2018 which includes New Molecular Entities (NMEs) and new biologics. A total of 46 applications were approved by the FDA during these three months.
Following are the percentages of various dosage form classifications in this quarter- 28.2% tablet, 15.2% capsule, 37% injectable, 2.2% oral solution, 2.2% inhalation solution, 2.2% powders for inhalation, and 13% miscellaneous. Miscellaneous dosage forms include film, aerosol, cloth, implant, insert, lotion, and system. Following are the percentages of NDA submission classes: Type 1 (New Molecular entity)– 33%, Type 2 (New active ingredient) – 4%, Type 3 (New Dosage form)-13%, Type 4 (New combination) – 6%, Type 5 – (New formulation or new manufacturer) – 22%, and BLA/tentative approvals – 22%.
AcelRx Pharmaceuticals Inc. received approval for DSUVIA which is the first and only sublingual tablet approved for acute pain. DSUVIA is a 30 microgram sufentanil tablet in a single-dose, pre-filled applicator for under the tongue (sublingual) administration by a healthcare professional only in certified medically supervised settings.
Mayne Pharma received approval of Tolsura™ (itraconazole capsules) for the treatment of certain fungal infections. Mayne used SUBA technology for the Tolsura. SUBA technology is a novel technology for enhancing the bioavailability of poorly soluble drugs. The technology utilizes a solid dispersion of drug in a polymer to improve the absorption of drugs in the gastrointestinal tract to achieve “super bioavailability” compared to conventional formulations. This dispersion improves the dissolution of poorly soluble drugs compared to their normal crystalline form.
EyePoint Pharmaceuticals, Inc. received approval of Yutiq™ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Yutiq utilizes the company’s Durasert™ drug delivery technology and is a non-bioerodible intravitreal micro-insert containing 0.18 mg fluocinolone acetonide, designed to release consistently over 36 months. The approval of Yutiq is an advancement in the treatment of non-infectious posterior segment uveitis, as it delivers consistent dosing without the peaks and valleys of current local corticosteroids.