Neelam Sharma, MS
Lavanya Kundurthy, BE
Hemant N. Joshi, PhD, MBA - Tara Innovations LLC, [email protected]; www.tara-marketing.com
This quarterly review on new drug applications (NDAs) contains data for applications approved during the first quarter of 2022. A total of 32 applications were approved by the FDA during these three months.
The first quarter 2022 NDA approvals were divided into 10 different dosage forms. The following are the percentages of those dosage forms/routes of administration – 18.75% tablets, 9.38% capsules, 34.38% injectables, 6.25% nasal, 6.25% oral suspension, 3.12% oral solution, 3.12% inhalation gas, 6.25% ophthalmic, 3.12% oral granules and 9.38% topical or transdermal. Clearly, injectable formulations are still preferred.
The NDAs are divided based on their submission classification as follows: Type 1 (New Molecular Entity) – 6, Type 2 (New Active Ingredient) – 2, Type 3 (New Dosage Form) – 9, Type 4 (New Combination) – 3, Type 5 (New Formulation or Manufacturer) – 7, Type 8 (Partial Rx to OTC Switch) – 1, Gas – 1, BLA (Biologics License Agreement) – 5. Two products had a dual classification.
The following is the distribution based on the physiological system where these medicines are targeted – skin (12.5%), eyes (6.25%), nervous system (21.88%), cancer (18.75%), cardiovascular (12.5%), kidneys (3.13%), reproductive (3.13), respiratory (9.38%) and infectious diseases (12.5%).
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent and it is a first- in - class treatment. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177, which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer, including mCRPC. Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage, which can lead to cell death.
Quviviq (Daridorexant HCl) tablets contain a new molecular entity. It is prescribed to patients who have trouble falling asleep or staying asleep. It is a controlled substance as it can be abused and can lead to dependence. If taken with a meal, the drug absorption can be delayed. It may show some side effects such as - worsening depression and suicidal thoughts, and temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
Acuvue Theravision with Ketotifen is a medical device used as a daily disposable contact lens for prevention of ocular itch due to allergic conjunctivitis and correction of refractive ametropia. It is a drug[1]eluting contact lens containing ketotifen, an H1 receptor antagonist, for topical administration to the eyes. Eye drops containing benzalkonium chloride should not be used simultaneously with this product.
Enjaymo is the first and only approved treatment in cold agglutinin disease (CAD). Enjaymo is used to decrease the need for red blood cell transfusion due to the breakdown of red blood cells (hemolysis) in adults with CAS. Enjaymo can lower the ability of the immune system to fight infections.
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!