Pulse Newsletter | Volume 7 - Issue 23

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

December 1, 2025

Contributors
Chief Authors: Rebecca Waite, PharmD & Christina Ramsay, PharmD
Contributing Authors: Xintian Wu, PharmD/MBA Candidate, and Jessica Lin PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Drug to Treat Moderate to Severe Vasomotor Symptoms Due to Menopause

On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved Lynkuet® (elinzanetant) capsules for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VMS include hot flashes and night sweats caused by hormonal changes due to aging. Menopause, which typically occurs in women around ages 45-55, results in a decrease in levels of the hormones estrogen and progesterone. The reduction in these hormones can cause various symptoms of menopause, including VMS. Treatment of VMS may include prescription hormones to supplement declining estrogen and progesterone levels or non-hormonal prescription drug therapy, like Lynkuet® or Veozah® (fezolinetant), which is a similar drug available in the market.

Lynkuet® is available as a 60mg capsule, and the recommended dose of Lynkuet® is 120mg (two 60mg capsules) taken by mouth once a day at bedtime with or without food. Do not take Lynkuet® with grapefruit juice. Lynkuet® is contraindicated with pregnancy, meaning that the drug should not be taken if pregnant due to risk of harm to the unborn baby. Side effects associated with Lynkuet® include headache, fatigue, dizziness and excessive drowsiness. Due to the risk of excessive drowsiness, the manufacturer advises caution with driving or other activities like operating machinery until the side effects are resolved. Other warnings and precautions include the risk of seizures and an increase in liver enzymes, which should be monitored by a health care provider during treatment.

The safety and efficacy of Lynkuet® was shown in three randomized, double-blind, placebo-controlled multicenter clinical trials, called OASIS 1, OASIS 2 and OASIS 3. The study included 1,420 adult women ages 40-65. The primary endpoint of the trials was change in VMS frequency and severity compared to the patient’s starting symptoms. The results of the studies showed a statistically significant reduction in VMS compared to placebo as demonstrated by at least 2 fewer hot flashes per day as well as a reduction in severity of VMS. Lynkuet® is currently available and costs about $625 per month, which is slightly more expensive than Veozah®, which is about $570 per month.

Drug Safety

Atorvastatin Tablets Recalled Due to Improper Dissolution

On October 10, 2025, the FDA announced a Class II recall of atorvastatin tablets due to poor tablet quality leading to improper dissolution, which means that the drug does not dissolve properly in the body after swallowing. Since the tablets must dissolve before the active ingredient can be absorbed into the bloodstream, patients taking the impacted drug might not receive the appropriate dose. A Class II recall indicates that a drug could cause “temporary or medically reversible adverse health outcomes”. The recalled atorvastatin tablets were manufactured by Alkem Laboratories, which is based in India, and distributed by Ascend Laboratories, which is based in New Jersey. The recall was initially announced in late September and impacted over 140,000 bottles of atorvastatin of various count sizes. Generic drug manufacturers are required to complete quality assurance testing on every batch of drug using random drug samples to help ensure that their drugs are safe and will work as intended. The testing helps confirm that the generic drug contains the right amount of active ingredient and does not contain any contamination, which could harm a patient. If the drug is found to be out of compliance with standards, the drug must be recalled and any remaining drug in the defective batch must be disposed of.

Atorvastatin is a generic medication used to lower cholesterol levels and reduce the risk of adverse cardiovascular events. Patients who may be taking the recalled atorvastatin are advised to contact their doctor or pharmacy immediately for guidance and to confirm if their medication is affected by the recall. The drug manufacturer is printed on the prescription label, so patients should check to see if their medication came from Ascend Laboratories. Product that was manufactured from November 2024 through September 2025 was impacted by the recall and can be identified using a lot number, which is a unique number that can identify a specific batch of drug. Health care professionals and patients may submit any product safety concerns regarding atorvastatin through the FDA’s MedWatch Reporting Program online.

From the Pharmaceutical Industry

FDA Announces Plan to Accelerate Biosimilar Development and Lower Drug Costs

On October 29, 2025, the FDA announced new draft guidance intended to reduce the current requirement of clinical testing prior to the launch of biosimilar drugs. Biologic medications are a type of drug derived from living organisms. They are used to treat a variety of chronic autoimmune conditions, such as psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease and ulcerative colitis. According to the FDA, biologic drugs account for about 5% of all prescriptions in the U.S. but are responsible for about 51% of the country’s total drug spend. The average cost of biologic drugs is estimated as $50,000-$100,000 per year or higher, depending on the drug and the dose prescribed, as some autoimmune diseases require higher doses or more frequent dosing to be effective. Biologic drugs are expensive to develop and bring to market due to the high costs associated with research and development, including the cost of clinical trials to demonstrate the drug’s safety and efficacy, which is required prior to FDA approval.

When the patent expires for a biologic drug, FDA-approved biosimilar medications from other manufacturers become a lower cost alternative for treatment. Biosimilars have the same sources of components and do not pose clinically meaningful differences from the original biologic drug. According to the FDA, the cost of comparative efficacy studies, which are currently required for biosimilar drugs, is about $24 million dollars and takes between 1 and 3 years. The new draft guidance will change this requirement with the intent to allow manufacturers of biosimilar drugs to bring their products to market more quickly.

The FDA is also changing the requirements for biosimilars to demonstrate “interchangeability”. Current rules require additional drug studies for a biosimilar to be deemed “interchangeable”, meaning it can be automatically substituted for the reference drug. The FDA notes that this requirement is not currently in place for generic drugs, and the additional testing can slow down the approval process and create market confusion between biosimilars and the original reference drug. By reducing barriers to market entry, the goal is to have additional options available for physicians and patients to treat their conditions safely and effectively at a lower cost, as biosimilars have an average list price that is between 50-80% lower than the original reference product.