Your source for the latest industry trends and drug information news.
Volume 5 | Issue 3
February 15, 2023
Contributors:
Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate
On January 11, 2023, the U.S. Food and Drug Administration (FDA) approved Airsupra™ (albuterol/budesonide) for the prevention or as-needed treatment of asthma attacks in adults. Asthma is a long-term chronic condition that affects a patient’s lungs, causing their airways to become narrowed. This condition can lead to asthma attacks, also known as exacerbations, which are characterized by chest tightness, difficulty breathing, wheezing and coughing. Over 21 million adults have asthma in the United States, and over 8.5 million asthma exacerbations are experienced per year in this population. Patients with asthma are often prescribed a maintenance inhaler which is taken every day to manage symptoms, along with a fast-acting rescue inhaler used to prevent and treat exacerbations when they occur. Airsupra™ is the first inhaler to be approved in the U.S. that combines the ingredients of both a maintenance inhaler and a rescue inhaler. The ingredient albuterol helps to alleviate symptoms of an exacerbation, while the budesonide controls the underlying inflammation experienced in the lungs. Airsupra™ was tested in two Phase III clinical trials and was proven to significantly reduce risk of severe exacerbations while also improving lung function. This medication is provided as a pressurized metered-dose inhaler and is taken as two puffs as needed for asthma symptoms.
On February 2, 2023, the FDA announced Global Pharma Healthcare’s voluntary recall of Artificial Tears Lubricant Eye Drops, which are used to relieve eye discomfort due to dryness or irritation. The recall is due to potential microbial contamination of the product. This recall includes all lots of the 15 milliliter bottles that have been distributed by Aru Pharma/EzriCare, LLC and Delsam Pharma. Global Pharma Healthcare has notified distributors of this recall, and Aru Pharma/EzriCare, LLC and Delsam Pharma are encouraging wholesalers, retailers and customers to discontinue use of this product. There have been 55 reports of adverse events from the use of contaminated Artificial Tears Lubricant Eye Drops, including permanent vision loss, eye infections and one death resulting from a bloodstream infection. Due to the severity of these events, consumers are advised to contact their health care providers if they experience any side effects from this product. Adverse reactions relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
On January 31, 2023, the American Hospital Association shared a press release announcing the Biden Administration’s plan to end the COVID-19 national and public health emergency (PHE) declaration on May 11, 2023. Originally set to expire on March 1 and April 11 of this year, respectively, this extension would allow for a smoother adjustment period to resume normal operations in many facets of our nation’s health care system and government operations. The Statement of Administration Policy was released on January 30, 2023, and explains “this wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE.” This extension will impact hospitals, nursing homes and Medicaid which has continued to provide coverage to individuals to prevent lapses in benefits. Local communities, schools and businesses will be unaffected by the change and will continue with day-to-day operations as they are now.
New Drug Approval: Brenzavvy™ (bexagliflozin)
Oral tablet approved to improve glucose control in adult patients with type 2 diabetes mellitus. [01/20/2023 – THERACOSBIO]
Keveyis® (dichlorphenamide) tablets
Indication: Treatment of periodic muscle weakness or loss of muscle movement due to an inherited condition that causes high or low potassium levels in the blood.
Dosage Form/Strength: 50mg oral tablet
Average Wholesale Price (AWP): Generic = $10,203 | Brand = $11,929
