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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 14
July 15, 2022

Chief Authors: Bonnie Broczkowski & Colleen Peehler
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

COVID-19 Vaccine Updates – FDA Recommends Additional Omicron Coverage in Booster Doses

On June 30, 2022, the U.S. Food and Drug Administration (FDA) published a recommendation for COVID-19 vaccine manufacturers to update the composition of future booster doses to include additional coverage against the omicron variant. As the SARS-CoV-2 virus evolves, highly transmissible variants such as omicron continue to spread rapidly with symptoms ranging from mild to severe illness. The most severe outcomes, such as hospitalization and death, have been greatly reduced with currently approved and authorized COVID-19 vaccines. Current COVID-19 vaccines provide some protection against the omicron variant, but studies have shown that the effectiveness of these vaccines decreases over time. Therefore, the FDA has advised vaccine developers to update the booster doses of their COVID-19 vaccines to include an omicron component. The two component (bivalent) booster vaccines are expected to be available for administration in fall 2022. This recommendation is specific for booster vaccines, so no changes are expected for primary vaccination. The Centers for Disease Control and Prevention (CDC) recommends that all eligible individuals receive up-to-date COVID-19 vaccination, including the primary series and booster doses. COVID-19 vaccination, including the primary series and booster doses. 

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Drug Safety

FDA Announces Morphine Recall Due to Incorrect Labels

On June 28, 2022, the FDA announced that Bryant Ranch Prepack Inc. has voluntarily recalled two lots of their Morphine Sulfate Extended-Release products due to incorrect labeling. One lot, consisting of 10 compromised bottles, contained Morphine Sulfate 30mg ER tablets but was labeled as 60mg. Patients receiving this decreased dose are at risk of untreated pain and withdrawal symptoms. The other mislabeled lot, also consisting of 10 compromised bottles, contained Morphine Sulfate 60mg ER tablets but was labeled as 30mg. Patients that receive this elevated dose are at risk of overdose and possibly death. These products were labeled and distributed by Bryant Ranch Prepack Inc. The company has notified its distributors and customers regarding this recall.   Consumers who have the recalled products should discontinue use immediately and report any adverse reactions or quality problems to their physician/health care provider as well as the FDA's MedWatch Adverse Event Reporting program. To date, Bryant Ranch Prepack Inc. has not received any reports of adverse events related to this recall.

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From the Pharmaceutical Industry

FDA Approves Expanded Indication for Vaxneuvance™  

On June 26, 2022, the FDA approved Merck’s Vaxneuvance™ for patients ages 6 weeks through 17 years old in addition to the previously approved age group of 18 years and older. Vaxneuvance™ is a pneumococcal vaccine that helps to protect against invasive pneumococcal disease (IPD) such as bacteremia, which is an infection in blood, and meningitis, which is an infection in the fluid and protective tissue surrounding the brain and spinal cord. The vaccine provides protection for 15 different types of pneumococcus bacteria, 3 of which are in the top 5 strains associated with childhood IPD. The approval was granted after evaluating the safety and efficacy data from 7 randomized, double-blind clinical trials in pediatric patients. Results showed that Vaxneuvance™ provides overall comparable protection in pediatrics with current pneumococcal vaccine, PCV13, and better protection in some types of pneumococcus bacteria. Some common side effects may include injection site reaction, irritability, headache and muscle aches. Vaxneuvance™ is a 4-dose series vaccine for pediatric patients. The series should be given at 2 months old, 4 months old, 6 months old and last injection given at 12 through 15 months old. It can also be given as a single dose in children over 2 years old who did not complete a series with another pneumococcal vaccine. Vaxneuvance™ should not be used in patients who have or have had a severe allergic reaction to any ingredients of the vaccine or to diphtheria toxoid. The CDC’s Advisory Committee on Immunization Practices will soon make recommendations on the use of the vaccine in pediatrics.

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FDA Approvals

New FDA Approvals

New Formulation:  Relexxii® (methylphenidate hcl)
Extended-release oral tablets approved for treatment of Attention Deficit Hyperactivity Disorder (ADHD), for adults up to 65 years old and pediatric patients  6 years and older. [06/23/2022–OSMOTICA PHARM CORP]

New Dosage Form:  Venlafaxine
Extended-release oral tablets approved for the treatment of Major Depressive Disorder and Generalized Anxiety Disorder. [06/29/2022 – ALMATICA]   

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New Generics

New Generics Entering the Marketplace

Toviaz® (fesoterodine fumarate) 
Indication: Overactive Bladder  
Dosage Form/Strength: 4 MG, 8 MG  Tablets
Average Wholesale Price (AWP): Generic = $405.98 | Brand = $451.86