Your source for the latest industry trends and drug information news.
Volume 7 | Issue 8
April 15, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On March 28, 2025, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test. This is the first diagnostic tool for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed at home. The test is for females with or without symptoms and delivers results in approximately 30 minutes. If these infections are diagnosed, they can be treated with antibiotics. According to the Centers for Disease Control and Prevention (CDC), more than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023, and trichomoniasis is estimated to affect approximately 2.6 million American adults. If left untreated, these infections can cause serious health complications, including infertility.
The Visby Medical Women’s Sexual Health Test is a single-use test. The test includes a vaginal swab for sample self-collection and a powered testing device that communicates securely to the Visby Medical App, displaying results when the test is complete. Patients who test positive for any of the infections should seek treatment with their health care provider. Clinical studies demonstrated that the test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples. However, there are still risks for false positive and false negative test results so patients exhibiting symptoms should outreach to their medical provider, even if the result is negative. Visby Medical Women’s Sexual Health Test was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This authorization is a significant step toward expanding access to sexual health testing, which can lead to earlier diagnosis, increased treatment and reduced spread of infections.
On February 25, 2025, Ascent Consumer Products Inc. issued a voluntary nationwide recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to microbial contamination. It was found to be contaminated with Staphylococcus aureus, a type of bacteria that can cause infections. Nasal washes help to clear the nasal passages of mucus or allergens to relieve symptoms like congestion, a runny nose or irritation. Using a contaminated nasal wash system can introduce bacteria into the body and potentially lead to serious life-threatening infections, especially in patients with nasal inflammation or injuries. Potential infections could occur in the blood, heart, bones, joints, brain or spinal cord and can result in significant health problems.
The lot number of the affected products is 024122661A1, with an expiration date of 12-31-2027. The SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is packaged in a carton that contains the squeeze bottle and 30 saline packets. Ascent Consumer Products Inc. is notifying its distributors and customers by email to stop distribution and remove the product from inventory. Consumers with the product should stop using and return it to the place of purchase or dispose of it. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program. To date, no adverse events have been reported.
On March 28, 2025, the FDA approved Qfitlia™ (fitusiran) to prevent or reduce bleeding episodes in patients 12 years or older with hemophilia A or hemophilia B. Hemophilia A and hemophilia B are genetic bleeding disorders in which the blood does not clot appropriately due to the dysfunction of coagulation factor VIII or IX, leading to uncontrolled bleeding. Patients with hemophilia may bleed more easily and for a longer time after injury compared to those without hemophilia. Serious spontaneous bleeding in muscles, joints and organs can lead to life-threatening conditions.
Qfitlia™ is administered under the skin and is initially given once every two months. It increases the amount of thrombin, a protein critical for blood clotting, by reducing the amount of antithrombin that inactivates it, thereby improving the ability to stop bleeding. The efficacy and safety of Qfitlia™ have been established in clinical trials. It showed a greater than 70% reduction in bleeding rate compared with those who received on-demand treatment with clotting factor concentrates and bypassing agents. Qfitlia™ has a boxed warning for blood clotting events and gallbladder disease. Regular blood tests are also required due to the risk of liver toxicity. Common side effects reported with Qfitlia™ injection include nasal congestion, fever, coughing, viral infection and bacterial infection.
New Drug: Blujepa (gepotidacin)
Oral tablets approved for the treatment of bladder infections known as uncomplicated urinary tract infections (uUTI) caused by certain types of bacteria, in female patients 12 years and older weighing at least 88 pounds. [3/25/25 - GLAXOSMITHKLINE LLC]
Auryxia® (ferric citrate)
Indication: For the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis, and to treat iron deficiency anemia in patients with CKD not on dialysis.
Dosage Form/Strength: 210mg oral tablets
Average Wholesale Price (AWP): Generic = $3,176 | Brand = $3,344
