November 11 RxAdvocate November, 2021 — Newsletter
FDA Approves:
- Pfizer’s COVID-19 Vaccine for Kids Aged 5-11
- Eye Drops for Presbyopia
- First Interchangeable Biosimilar Insulin
October 29, 2021 – The U.S. Food and Drug Administration expanded the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5-11 years of age. The Pfizer-BioNTech COVID-19 Vaccine for children 5-11 years is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). In the U.S. children 5-11 years make up 39% of COVID-19 cases in individuals younger than 18 years. According to the CDC, approximately 8,300 COVID-19 cases in children 5-11 years of age resulted in hospitalization and as of October 17, 2021, 146 deaths from COVID-19 have been reported in this population.
The US Food and Drug Administration has approved the first eye drop, pilocarpine hcl opthalamic solution 1.25% (Vuity), to treat presbyopia, also known as age-related blurry near vision, in adults. Presbyopia is a common, progressive condition that reduces the eye’s ability to focus on near objects, affecting most adults over the age 40. Pilocarpine HCl ophthalmic solution 1.25% (Vuity) works in part by contracting the pupil size in a pinhole-camera effect. It could allow people with good distance vision to forego their reading glasses in many situations and might expand interest in refractive surgery such as LASIK.
FDA Approves 1st Interchangeable Biosimilar Insulin
The first interchangeable biosimilar insulin product, Semglee, has been approved by the FDA. Semglee can be used to improve glycemic control for types 1 and 2 diabetes mellitus in pediatric and adult patients. This approval will allow access to additional safe, high-quality treatment options at potentially lower costs for the more than 34 million diabetic patients in the United States.
RxConnection Organizational Announcements
Follow Us On Linkedin!
Contact us
Orlando.Neal@rxconnectionllc.com