PDR Drug Update - April 2025

Introduction of a Next-Generation, Non-Hormonal IUD

Intrauterine devices (IUDs) are a prevalent option in contraceptive care, offering an effective and reversible solution for individuals seeking long-term pregnancy prevention. Advancements in technology and materials have led to the development of a variety of IUD products, each with its unique characteristics designed to help accommodate different patient needs. Now, for the first time in four decades, there is a new hormone-free IUD option becoming available.

IUDs are small, T-shaped devices that are placed in the uterus by a trained healthcare provider to prevent pregnancy. IUDs are 99% effective. Currently, IUDs are classified into two primary types: hormonal IUDs and copper IUDs. Both types work primarily by preventing sperm from fertilizing an egg, but they accomplish this through different mechanisms. Hormonal IUDs are among the most commonly prescribed contraceptive devices. There are four of this kind available in the US: Kyleena, Liletta, Mirena, and Skyla. These devices all use the synthetic progestin levonorgestrel released in small amounts directly into the uterus. This hormone thickens cervical mucus, which helps prevent sperm from reaching the uterus, and thins the endometrial lining, thereby reducing the likelihood of implantation.

Hormonal IUDs offer benefits compared to oral contraceptives due to their ability to deliver a comparatively lower dose of hormones. They often result in fewer or less severe side effects that can be associated with hormonal treatments, including nausea, weight gain, and impact on mood. Patients who use hormonal IUDs may experience lighter periods that have reduced cramping and pain. Periods may even cease to occur in certain individuals. IUDs can remain in place for years, depending on the brand and the patient. Unfortunately, some patients are not able to tolerate the insertion of an IUD due to pain that can be severe.

The copper IUD, such as the currently available Paragard, is one of the oldest and most widely used forms of contraception. This device is non-hormonal and relies on the spermicidal properties of copper to prevent pregnancy. When inserted into the uterus, the copper IUD releases copper ions, which impair sperm motility and viability, reducing the chance of sperm reaching the egg. Copper IUDs are a good option for patients who prefer to avoid hormones or have contraindications to hormonal contraceptives. Unfortunately, many patients have described experiencing heavier and more painful periods after copper IUD insertion, which can be a significant downside.

The Miudella IUD is a recently FDA-approved product that adds to the growing range of IUD options available to patients and prescribers. It has been developed to reduce adverse reactions and other issues of past devices. Miudella is a new, hormone-free IUD indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years. It is designed as a low-dose copper IUD, built with a flexible frame of nitinol and in a smaller size than other existing IUDs. This material is an alloy with properties that allow it to conform to the unique shapes of varying uteruses. Its insertion involves a newly designed tube that is shaped in a way that offers a more comfortable experience for the patient.

Miudella represents an exciting advancement in contraceptive technology, providing another choice for women seeking safe, long-term pregnancy prevention. As always, the selection of an IUD should be guided by individual patient preferences, health history, and a thorough discussion with a healthcare provider to explore the benefits and risks. Stay informed about advances in long-acting reversible contraception by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Arbli

The FDA has approved Arbli (losartan potassium) oral suspension, 10mg/mL. Arbli is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy, and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. Learn more about Arbli

Blujepa

The FDA has approved Blujepa (gepotidacin) for the treatment of female adults (≥40kg) and pediatric patients (≥12 years, ≥40kg) with uncomplicated urinary tract infections caused by certain susceptible microorganisms. Learn more about Blujepa

Conexxence and Bomyntra

The FDA has approved Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These denosumab biosimilars are approved for all indications of the reference products: Prolia (denosumab) and Xgeva (denosumab), respectively. Learn more about Conexxence and Bomyntra

Encelto

The FDA has approved Encelto (revakinagene taroretcel-lwey) for the treatment of adults with idiopathic macular telangiectasia type 2. Learn more about Encelto

Gozellix

The FDA has approved Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection). Gozellix, after radiolabeling with ⁶⁸Ga, is indicated for PET scanning of PSMA-positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen level. Learn more about Gozellix

Omlyclo

The FDA has approved Omlyclo (omalizumab-igec) as the first and only biosimilar designated as interchangeable with Xolair (omalizumab) for the treatment of moderate-to-severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria. Learn more about Omlyclo

Qfitlia

The FDA has approved Qfitlia (fitusiran), the first antithrombin-lowering therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. Learn more about Qfitlia

Vykat XR

The FDA has approved Vykat XR (diazoxide choline) extended-release tablets for the treatment of hyperphagia in adults and children aged 4 years and older with Prader-Willi syndrome. Learn more about Vykat XR

FDA New Indications

Amvuttra

The FDA has approved Amvuttra (vutrisiran) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits. Learn more about Amvuttra

Cabometyx

The FDA has approved Cabometyx (cabozantinib) for the treatment of 1) adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and 2) adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors. Learn more about Cabometyx

Fabhalta

The FDA has approved Fabhalta (iptacopan) for the treatment of adults with C3 glomerulopathy, to reduce proteinuria, making it the first and only treatment approved for this condition. Learn more about Fabhalta

Furoscix

The FDA has approved an expanded indication for Furoscix (furosemide) injection to include treatment of edema in patients with chronic kidney disease. Learn more about Furoscix

Gvoke VialDx

The FDA has approved Gvoke VialDx (glucagon) for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Learn more about Gvoke VialDx

Imfinzi

The FDA has approved Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy for the treatment of adult patients with muscle-invasive bladder cancer. Learn more about Imfinzi

Keytruda

The FDA has granted traditional approval to Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1). Learn more about Keytruda

Neffy

The FDA has approved Neffy (epinephrine) 1mg nasal spray for the treatment of type I allergic reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to <30kg. Learn more about Neffy

Pluvicto

The FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with an androgen receptor pathway inhibitor therapy and are considered appropriate to delay chemotherapy. Learn more about Pluvicto

TNKase

The FDA has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults. TNKase is also indicated to reduce the risk of death associated with acute ST-elevation myocardial infarction. Learn more about TNKase

Tremfya

The FDA has approved Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for the treatment of adults with moderately to severely active Crohn’s disease. Learn more about Tremfya

FDA Recalls

Dr. Reddy’s Levetiracetam

Dr. Reddy’s Laboratories is recalling one batch/lot No: A1540076 of levetiracetam in 0.75% sodium chloride injection, 1000mg/100mL single-dose infusion bags to the consumer level. The product is being recalled because the infusion bag is incorrectly labeled as levetiracetam in 0.82% sodium chloride injection 500mg/100mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as levetiracetam in 0.75% sodium chloride injection 1000mg/100mL. Learn more about the Dr. Reddy’s levetiracetam recall

New York Wholesale Group Zaarah Herbals

New York Wholesale Group is recalling Zaarah Herbals Rasayan Churan, Zaarah Herbals Gurmar Powder, Zaarah Herbals Vasaka Powder, and Zaarah Herbals Bhringraj Powder to the consumer/user level because it has the potential to be contaminated with elevated levels of lead and arsenic. Learn more about the New York Wholesale Group Zaarah Herbals recall

One Source Nutrition Vitality

One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the consumer level. FDA analysis has found the product to be tainted with unapproved sildenafil and tadalafil. Learn more about the One Source Nutrition Vitality recall

April 2025