Your source for the latest industry trends and drug information news.
Volume 7 | Issue 13
July 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD & Christina Ramsay, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate, Xintian Wu, PharmD/MBA Candidate, and Jessica Lin PharmD/MBA Candidate
On June 5, 2025, the U.S. Food and Drug Administration (FDA) approved Widaplik™ (telmisartan, amlodipine, indapamide) for the treatment of high blood pressure in adults. Widaplik™ is the only FDA-approved medication containing a combination of three different medications for the initial treatment of high blood pressure. Blood pressure is the force of blood against the walls of the arteries. Normal blood pressure is 120/80mmHg. High blood pressure, or hypertension, is a common chronic condition affecting many adults and is defined by blood pressure readings of 140/90mmHg or higher. It typically does not produce symptoms, but it is a risk factor for cardiovascular diseases, such as heart disease, stroke and heart failure if left uncontrolled. The target patient population for Widaplik™ is intended to be adults who may require multiple medications to achieve their blood pressure goal, set by their health care provider.
Widaplik™ was evaluated against placebo and its component drugs in two clinical trials and demonstrated efficacy in controlling blood pressure. Side effects include risk of low blood pressure, sugar and electrolyte imbalances, impaired kidney function, acute glaucoma and high uric acid levels. Widaplik™ carries a serious risk of harm to unborn babies and should be stopped immediately if pregnancy is detected. It will be available in three different strengths and is intended for once-daily dosing. Widaplik™ is expected to be commercially available sometime in late 2025.
On June 6, 2025, Church & Dwight Co., Inc. issued a voluntary nationwide recall of all lots of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs. The recall is due to potential fungal contamination in the cotton swabs. Consumers should stop using these products immediately as the fungal contamination in the swabs may present serious health risks. Children and individuals with an underlying medical condition or compromised immune system are at highest risk of potentially severe infections. Also of particular concern, use in individuals with inflammation or injury of the nasal cavity could allow the fungus to gain access to the bloodstream and be transported throughout the body due to breaks in the mucous membranes. To date, no serious adverse events associated with this recall have been reported. Individuals with questions about this recall may contact the manufacturers’ consumer relations team at (800) 981-4710. Any adverse events associated with these products should be reported to the FDA’s MedWatch Adverse Event Reporting program.
On June 11, 2025, the FDA approved Ibtrozi® (taletrectinib) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Fusion errors in the ROS1 gene, which occur in approximately 1-2% of patients with lung cancer, can be determined by blood or tissue testing. If a fusion error of the ROS1 gene is present, an individual is identified as ROS1-positive. Utilizing genetic biomarkers, or specific sequences in an individual’s DNA, can be used in certain types of cancer treatments to determine the best course of therapy.
The efficacy of Ibtrozi® was tested in 270 patients in two single-arm, open-label clinical trials, meaning all participants enrolled in the clinical trials received therapy with Ibtrozi®. Efficacy was evaluated by the overall patient response rate, which varied from 52% to 90% depending on an individual’s previous treatment history, and duration of response, with most participants having a response of 6 months or more. The recommended dose of Ibtrozi® is 600mg taken by mouth once a day on an empty stomach. Warnings and precautions for Ibtrozi® include liver toxicity, inflammation of the lungs, irregular heartbeat (QTc prolongation), high uric acid levels, muscle pain with elevated blood levels of creatine phosphokinase (CPK), bone fractures and risk of fetal harm. In addition, common side effects may include diarrhea, nausea, vomiting, dizziness, rash, constipation and fatigue. Ibtrozi® (taletrectinib) was granted priority review by the FDA, which is a process to expedite the review of drugs that treat rare cancers or other rare medical conditions for which the drug may offer a treatment advantage over existing therapies, as well as an orphan drug designation.
New Drug: Enflonsia™ (clesrovimab-cfor)
Intramuscular injection approved to prevent lower respiratory tract disease due to respiratory syncytial virus (RSV) in infants born during or entering their first RSV season. [6/9/2025 – Merck & Co, Inc]
Fycompa® (perampanel)
Indication: For the treatment of epilepsy in patients 4 years and older with partial-onset seizures and as an add-on treatment for patients 12 years and older who experience generalized tonic-clonic (“grand mal”) seizures.
Dosage Form/Strength: 2mg, 4mg, 6mg, 8mg, 10mg and 12mg tablets
Average Wholesale Price (AWP): Generic = $1,399 | Brand = $1,472
