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Pulse Newsletter

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

Volume 5 | Issue 15
September 1, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves First Oral Treatment for Postpartum Depression

On August 4, 2023, the U.S. Food and Drug Administration (FDA) approved Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD) in adults. This is the first oral medication approved to treat PPD. Categorized as a major depressive episode, PPD occurs after childbirth or during the late stages of pregnancy. PPD can be life threatening with symptoms of cognitive impairment, feelings of sadness, loss of energy, suicidal ideation, and thoughts of harming themselves or their child. Not only is it harmful to the mother, but it can affect the child’s physical and emotional development due to disruption in the maternal-infant bond. Zurzuvae was found to be safe and effective to treat PPD in two randomized, double-blind, placebo-controlled, multicenter studies. Study 1 patients received 50 mg of Zurzuvae or placebo for 14 days. Study 2 patients received equivalent of 40 mg Zurzuvae or placebo for 14 days. The primary objective was to observe the change in depressive symptoms on day 15. Patients in the Zurzuvae groups showed significant improvement in their symptoms as compared to the placebo groups. Improvement was still observed four weeks after the last dose of Zurzuvae. The most common side effects noted during the study were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. In addition, there is a boxed warning that the Zurzuvae may impact the ability to drive or perform other potentially hazardous activities so patients should not drive for at least 12 hours after taking the medication.  Zurzuvae received fast track and priority review from the FDA, and is expected to be available in the first quarter of 2024 as determined by the manufacturer, Sage Therapeutics, Inc.

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Drug Safety

FDA Advised to Not Use Tests Manufactured by Universal Meditech, Inc.

On August 11, 2023, the FDA made an announcement for consumers and patients to not use tests manufactured by Universal Meditech, Inc (UMI). These tests include: One Step Pregnancy Test, DiagnosUS One Step Ovulation Test, HealthyWiser UriTest 10 Parameter Reagent Test Strips for Urinalysis, HealthyWiser UriTest UTI Test Strips, HealthyWiser KetoFast Ketone Test Strips, HealthyWiser pH-Aware pH Test Strips, To Life hCG Pregnancy Urine Test, Am I Pregnant Pregnancy Midstream Test, DeTec hCG Pregnancy Urine Test, PrestiBio Pregnancy Strips, PrestiBio Rapid Detection Pregnancy Test Midstream, PrestiBio Ovulation Strips, PrestiBio Urinalysis Test Strip 10 Parameters, PrestiBio Ketone Test Strips, and PrestiBio Breast Milk Alcohol Test Strips. These tests have been distributed under the brand names of AC&C Distribution, LLC., HealthyWiser, Home Health US Inc., and Prestige Biotech Inc. Tests may have also been distributed by other distributors and may not have identified UMI as the manufacturer. UMI initiated a recall for their distributors, but not for the consumers. The FDA is unable to confirm the performance of these tests as safe and effective and has recommended that consumers do not use or purchase these tests, and consumers with any of these recalled tests should stop using and discard the tests. If patients or consumers tested with a Universal Meditech item, it is recommended to use a different product to repeat the test. Patients experiencing any adverse events related to the recall are advised to contact their physician or health care provider and report the event to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

CDC Announces Program to Provide Free COVID-19 Vaccines 

As the fall season approaches, the CDC announced the Bridge Access Program which will make COVID-19 vaccines available to adults who are uninsured or whose insurance will not provide free vaccines. As respiratory infections peak in the fall and winter seasons, this program will be extremely beneficial in population health and prevention. There are up to 30 million uninsured adults in the US and many other who will not receive free coverage for COVID-19 vaccines. The CDC will be working with local healthcare providers, health centers, and pharmacies to distribute and provide the free vaccines. Individuals over 6 months of age are encouraged to get a COVID-19 vaccine this year to prevent from severe illness, hospitalization and death.

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FDA Approvals

New FDA Approvals

New Drug: Izervay™ (avacincaptad pegol sodium)

Solution injected into the eye and approved for the treatment of geographic atrophy (which results in visual blind spots) that is due to age-related macular degeneration. [08/04/2023 – IVERIC BIO]

New Drug: Elrexfio™ (elranatamab-bcmm)

Subcuteneous injection approved for the treatment of relapsed or refractory multiple myeloma in patients who have received at least four prior lines of therapy. [08/14/23 – PFIZER]

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New Generics

New Generics Entering the Marketplace

Indocin® (indomethacin)

Indication: Pain and inflammation 

Dosage Form/Strength: 50mg suppository

Average Wholesale Price (AWP): Generic = $413 | Brand = $434