Neelam Sharma, MS; Lavanya Kundurthy, BE; and Hemant N. Joshi, PhD, MBA# -Tara Innovations LLC. # [email protected], www.tara-marketing.com
This quarterly review of new drug applications contains data for applications approved for the first time during the fourth quarter of 2022, which includes New Molecular Entities (NMEs) and new biologics. A total of 29 applications were approved by the FDA during these three months.
Approvals in the last quarter of 2022 were divided into seven different dosage forms. The following are the percentages of those dosage forms – 3.5% each for capsules, ophathamlic solutions, topical gels, and gas inhalation products, 6.9% oral solutions/ suspensions, 13.8% tablets, and 65.5% injectable formulations. Clearly, pharmaceutical companies are developing more injectable formulations in recent times. NDA’s can be divided in a different way – 17.5% Type I (new molecular entities), 6.9% Type 2 (the main basic molecule is known but a new salt, ester or derivatives are prepared), 6.9% Type 3 (new dosage form), 37.9% Type 5 (new formulation or new manufacturer) and 31.0% BLA. All the BLA’s are injectable formulation formulations, which would explain the high percentage (65.5%) of injectables.
Olpruva (sodium phenylbutyrate) is used to treat Urea Cycle Disorders. It is a dual coated medication that is prepared by mixing with water and taken as a drinkable suspension. It is provided in single-dose pouches along with a mix-aid (100% modified starch) packets.
Sunlenca (lenacapavir sodium) has been approved to treat people living with multi-drug resistant HIV. It has two dosage options. Option 1: Day 1 – 927 mg subcutaneous injection and 600 mg orally (2x300 mg tablets). Day 2: 600 mg orally (2x300 mg tablets). Option 2: Day 1: 600 mg orally (2x300 mg tablets). Day 2: 600 mg orally, Day 8: 300 mg orally and Day 15: 927 mg by subcutaneous injection. A maintenance dose of 927 mg subcutaneous injection every 26 weeks from the date of last injection is required.
Eschar is a dry, dark scab typically caused by a burn, by the bite of a mite or as a result of anthrax infection. Nexobrid (anacaulase-bcdb) has been approved to remove eschar caused by thermal burns. It has been approved as an orphan biological drug.
Imjudo (tremelimumab-acti) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy has been approved in the US for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).
Iyuzeh™ is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free. Iyuzeh™ is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK). Iyuzeh™ has demonstrated consistent IOP-lowering effects and proven tolerability across multiple trials in the U.S. and Europe. The inactive ingredients are: polyoxyl 40 hydrogenated castor oil, sorbitol, carbomer 974P, polyethylene glycol 4000, disodium edetate, sodium hydroxide (for pH-adjustment) and water for injections. One drop contains approximately 1.5 mcg of latanoprost.
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!