--- title: PDR Drug Update - October 2025 description: The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update --- # October 2025 PDR Drug Update  Type Drug Name Here Search - Lead Story - Latest FDA News - FDA Drug Information Changes - FDA Safety - Labeling Updates Lead Story ##### **Revised Guidance for Treating High Blood Pressure ** Arguably, the most modifiable and common risk factor for cardiovascular disease and stroke is high blood pressure. Nearly fifty percent of the population in the US is thought to have elevated pressure. Still, a far smaller number are receiving adequate treatment to control their hypertension and reduce related health risks and mortality. To help address the complexity of identifying patients in need, communicating management approaches, and implementing personalized care, the American College of Cardiology (ACC) and the American Heart Association (AHA) have issued a new comprehensive 2025 update to their preeminent guidelines for treating hypertension. The ACC/AHA, along with eleven other respected health societies, released the [2025 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults](https://www.jacc.org/doi/10.1016/j.jacc.2025.05.007) this August. The revamped edition replaces the guidelines that were last published nearly ten years ago, in 2017. Over that span of time, a substantial amount of new clinical data has been gathered, helping to inform the evidence-based recommendations that comprise the guidance in the resource. A notable change in the guideline is shifting the systolic blood pressure target, encouraging an ideal figure of ≤120 mmHg for those who can achieve it. The lower target for most is <130 mmHg, and supports encouraging early and aggressive lifestyle modifications in all adults whose blood pressure is above 120/80 mmHg. By establishing that high blood pressure control should begin at 120 and recommending pharmacological treatment starting at 130 if lifestyle changes do not help, there is a push to encourage patients gain control of their future health by staving off the risks that accompany high blood pressure. Lowering the risks of heart attack, stroke, kidney disease, and dementia is a significant goal shared by all healthcare providers and patients alike. Aiding the identification of what level of risk a patient may have is the [American Heart Association PREVENT™ Online Calculator](https://professional.heart.org/en/guidelines-and-statements/prevent-risk-calculator/prevent-calculator), which is recommended within the revised guidelines. The name PREVENT stands for “Predicting Risk of Cardiovascular Disease Events,” and is intended as a replacement for the Pooled Cohort Equation (PCE). The PREVENT tool combines cardiovascular and kidney/metabolic measures, as well as body mass index, and incorporates a broader age range than the PCE. As an example of the guidance provided through PREVENT calculations, if a stage 1 hypertension patient’s score equals a 10-year cardiovascular risk of >7.5%, then that patient should receive pharmacological therapy and incorporate lifestyle changes. If their PREVENT score is <7.5%, lifestyle modifications can be the initial treatment for up to 6 months, and then the patient can be reassessed. There are plans to integrate the calculator into the electronic medical record, which could help initiate those initial conversations between healthcare providers and patients sooner and make them more effective in resulting in shared decisions about when medication should begin or therapy should be increased. Among many revisions and new recommendations in the guidelines is an important modification calling for combination drug therapy to be initiated for stage II hypertension (blood pressure ≥140/90 mmHg). Previous recommendations leaned toward stepped care approaches, with various drugs added on top of one another to achieve blood pressure targets. Now the current guidelines emphasize the use of single-pill combinations. Medications that deliver ingredients offering blood pressure control through multiple mechanisms in one pill help patients achieve their health goals in a simplified way, as their adherence is often greatly improved. Research and development of new blood pressure medications has embraced the potential benefits of single-pill combinations, as demonstrated in the recently approved [Widaplik (amlodipine/indapamide/telmisartan) tablets, for oral use](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219423s000lbl.pdf). This approval represents a new offering that combines three separate medications into a single pill. Amlodipine is a dihydropyridine calcium channel blocker; indapamide, a thiazide-like diuretic; and telmisartan, an angiotensin II receptor blocker. The three drugs were all previously FDA-approved, and together provide complementary blood-pressure-lowering benefits for patients, without the need to take multiple pills. Advances in treating high blood pressure, such as revised guidelines and innovations like multi-drug formulations, are designed to help improve health by reducing cardiovascular and other health risks associated with increased blood pressure. The tools available to practitioners are becoming more precise and, hopefully, will continue to lead to improved blood pressure management and healthier, longer life spans. As guidelines and further approvals are attained, exciting advances in tailored therapy approaches will continue. Stay informed about emergent drug information by exploring [PDR by ConnectiveRx](https://www.pdr.net/?hsLang=en). You can also stay current by using the official PDR app, [*mobile*PDR](https://www.pdr.net/mobilepdr/?hsLang=en), which is available for free from your preferred app store. Latest FDA News ### FDA New Approvals ##### Enbumyst The FDA has approved Enbumyst (bumetanide) nasal spray for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults. [Learn more about Enbumyst](https://www.businesswire.com/news/home/20250915243998/en/Corstasis-Therapeutics-Announces-FDA-Approval-of-ENBUMYST-bumetanide-nasal-spray-for-the-Treatment-of-Edema-Associated-with-Congestive-Heart-Failure-Liver-Disease-and-Kidney-Disease) ##### Forzinity The FDA has approved Forzinity (elamipretide HCl) to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30kg. [Learn more about Forzinity](https://stealthbt.com/stealth-biotherapeutics-announces-fda-accelerated-approval-of-forzinity-elamipretide-hcl-the-first-therapy-for-progressive-and-life-limiting-ultra-rare-genetic-disease-barth-syndrome/) ##### Inlexzo The FDA has approved Inlexzo (gemcitabine) intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer with carcinoma *in situ*, with or without papillary tumors. [Learn more about Inlexzo](https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated) ##### Keytruda Qlex The FDA has approved Keytruda Qlex (berahyaluronidase alfa-pmph/pembrolizumab) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda (pembrolizumab). [Learn more about Keytruda Qlex](https://www.merck.com/news/fda-approves-mercks-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-injection-for-subcutaneous-use-in-adults-across-most-solid-tumor-indications-for-keytruda-pem/) ##### Subvenite The FDA has approved Subvenite (lamotrigine) oral suspension with indications for: adjunctive therapy in patients aged 2 years and older with partial-onset seizures, primary generalized tonic-clonic seizures, or generalized seizures of Lennox-Gastaut syndrome; conversion to monotherapy in patients aged 16 years and older with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug; and for maintenance treatment of bipolar disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. [Learn more about Subvenite](https://owppharma.com/owp-pharmaceuticals-announces-fda-approval-of-subvenite-lamotrigine-oral-suspension/) ##### Wayrilz The FDA has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. [Learn more about Wayrilz](https://www.sanofi.com/en/media-room/press-releases/2025/2025-08-29-21-50-18-3141825) ##### Zolymbus The FDA has approved Zolymbus (bimatoprost) ophthalmic gel 0.01% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. [Learn more about Zolymbus](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217307s000lbl.pdf) ### FDA New Indications ##### Koselugo The FDA has approved Koselugo (selumetinib) granules and capsules for pediatric patients aged 1 year and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The FDA previously approved selumetinib capsules for pediatric patients aged 2 years and older with NF1 who have symptomatic, inoperable PN. [Learn more about Koselugo](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213756Orig1s005lbl.pdf) ##### Opzelura The FDA has approved Opzelura (ruxolitinib) cream 1.5%, a topical Janus kinase inhibitor, for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised children aged 2 years and older whose disease is not well-controlled with topical prescription therapies, or when those therapies are not recommended. [Learn more about Opzelura](https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib) ##### Vonvendi The FDA has approved an expanded indication for Vonvendi (von Willebrand factor (recombinant)), expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. Vonvendi was previously approved for on-demand and perioperative use in adults with VWD and routine prophylactic use in adults with severe Type 3 VWD receiving on-demand therapy. [Learn more about Vonvendi](https://www.takeda.com/newsroom/newsreleases/2025/expanded-indication-vonvendi/) FDA Drug Information Changes ### FDA Labeling Changes ##### Vyjuvek The FDA has approved an updated label for Vyjuvek (beremagene geperpavec-svdt) that expands the eligible patient population to include patients with dystrophic epidermolysis bullosa from birth and provides patients with full flexibility regarding Vyjuvek application and managing wound dressings. The approval also allows for the application of Vyjuvek in a home setting by a healthcare professional, the patient, or a caregiver. [Learn more about Vyjuvek](https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-fda-approval-updated-vyjuvekr-label) ### FDA New Formulations ##### Camcevi ETM The FDA has approved Camcevi ETM (leuprolide mesylate) for the treatment of advanced prostate cancer. Camcevi ETM is a 21mg ready-to-use long-acting injectable formulation. Camcevi was previously available as a 42mg injectable emulsion for the same indication. [Learn more about Camcevi ETM](https://www.foreseepharma.com/en/news/category/press_releases/foresee_pharmaceuticals_announces_fda_approval_of_camcevi_etm_for_the_treatment_of_advanced_prostate_cancer) ##### Leqembi Iqlik The FDA has approved Leqembi Iqlik (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease. [Learn more about Leqembi Iqlik](https://media-us.eisai.com/2025-08-29-FDA-Approves-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-for-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease) ##### Otezla XR The FDA has approved Otezla XR (apremilast) tablets in adult patients with: active psoriatic arthritis, plaque psoriasis and who are candidates for phototherapy or systemic therapy, or oral ulcers associated with Behçet’s Disease and in pediatric patients aged 6 years and older and who weigh at least 50kg with: active psoriatic arthritis; or moderate-to-severe plaque psoriasis and who are candidates for phototherapy or systemic therapy. [Learn more about Otezla XR](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210745s000lbl.pdf) ### FDA New Dosing ##### Tremfya The FDA has approved a subcutaneous induction regimen of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis. [Learn more about Tremfya](https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-achieves-u-s-approval-for-subcutaneous-induction-in-adults-with-ulcerative-colitis-now-the-first-and-only-il-23-inhibitor-with-a-fully-subcutaneous-regimen) FDA Safety ### FDA Recalls ##### DermaRite Products - Expanded DermaRite Industries is expanding the voluntary recall initiated on July 16, due to potential microbial contamination identified as *Burkholderia cepacia* complex. Out of an abundance of caution, the voluntary recall has expanded to include approximately sixteen additional products and lots. [Learn more about the DermaRite products recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-expands-voluntary-nationwide-recall-due-potential-burkholderia-cepacia) ##### Green Lumber Green Lumber Holding is alerting consumers that counterfeit products misrepresented as genuine Green Lumber have been identified and may pose health risks. FDA testing detected tadalafil, an undeclared prescription drug, in products labeled as Green Lumber. Tadalafil is not an ingredient in any authentic Green Lumber product. [Learn more about the Green Lumber recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-lumber-holding-llc-issues-consumer-alert-counterfeit-products-following-fda-findings) ##### Unichem Pharmaceuticals Cyclobenzaprine HCl Unichem Pharmaceuticals is voluntarily recalling one lot of cyclobenzaprine HCl tablets, USP, 10mg, to the consumer level. The cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing meloxicam 7.5mg tablets. [Learn more about the Unichem Pharmaceuticals cyclobenzaprine HCl recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unichem-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-cyclobenzaprine-hydrochloride) ### FDA Alerts ##### Recommended Monitoring with Leqembi The FDA is recommending an additional, earlier magnetic resonance imaging monitoring prior to the 3rd infusion for patients with Alzheimer’s disease taking Leqembi (lecanemab). Earlier monitoring can identify individuals with amyloid-related imaging abnormalities with edema, which is characterized by brain swelling or fluid buildup.  [Learn more about the Leqembi drug safety communication](https://www.fda.gov/media/188468/download?attachment) ##### Clozapine REMS Removed The FDA removed the risk evaluation and mitigation strategy (REMS) for clozapine (currently marketed as Clozaril, Versacloz, and generics), effective June 13, 2025. [Learn more about the clozapine drug safety communication](https://www.fda.gov/media/188418/download?attachment) Labeling Updates ##### Labeling Updates - No updates this month ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net#website", "@type" : "Website", "name" : "", "potentialAction" : { "@type" : "SearchAction", "query-input" : "required name=search_term_string", "target" : { "@type" : "EntryPoint", "urlTemplate" : "https://www.pdr.net/?site-search={search_term_string}" } }, "publisher" : { "@id" : "https://www.pdr.net#organization" }, "url" : "https://www.pdr.net" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net/edrug-updates/oct2025#webpage", "@type" : "WebPage", "about" : { "@id" : "https://www.pdr.net#organization" }, "dateModified" : "2024-10-01T12:0000+0000", "datePublished" : "2025-10-03T13:3107+0000", "description" : "The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update\t", "inLanguage" : null, "isPartOf" : { "@id" : "https://www.pdr.net#website" }, "name" : "PDR Drug Update - October 2025", "url" : "https://www.pdr.net/edrug-updates/oct2025" } ```