FDA Approves Yorvipath for the Treatment of Hypoparathyroidism in Adults
Ascendis Pharma A/S announced the U.S. Food & Drug Administration (FDA) approved Yorvipath (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults.
Yorvipath is a prodrug of parathyroid hormone (PTH[1-34]), administered once daily, designed to provide continuous exposure to released PTH over the 24-hour dosing period.
Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs and affects an estimated 70,000 to 90,000 people in the United States.
Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the Potential for Particulate Matter and Leakage
B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.
The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
Risk Statement: There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.
B. Braun has notified its distributors and customers by an official recall notice sent via certified registered mail and has arranged for the return of all recalled products. Facilities and distributors that have the product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return.
Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to B. Braun’s Postmarket Surveillance Department by calling 1-833-425-1464.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug
No members of BeneCard PBF were affected by this recall. Administration.
FDA Approves Lymphir Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Citius Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
Lymphir is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant Tcells and Tregs. This is the first indication for Lymphir and the first FDA-approved product for Citius Pharma.
Lymphir provides another viable option in the treatment landscape with unique benefits to patients. It offers a novel mechanism of action designed to target and eradicate malignant T-cells while preserving healthy tissue. It is the only treatment option that targets the IL-2 receptors found in T-cell lymphomas and Tregs.
FDA Approves Zurnai Auto-Injector for the Emergency Treatment of Known or Suspected Opioid Overdose
Purdue Pharma L.P. announced the U.S. Food and Drug Administration (FDA) approved the Company’s new drug application for the Zurnai (nalmefene injection) Auto-Injector. Zurnai (zur nye) is a single-dose auto-injector that delivers 1.5mg of nalmefene hydrochloride per actuation.
Zurnai is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. Zurnai is intended for immediate administration as emergency therapy in settings where opioids may be present. Zurnai is not a substitute for emergency medical care.
Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
Baxter International Inc. is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.
Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.
Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000mL in VIAFLEX Plus Plastic Container-1 unit per pouch. This issue affects one lot of product code that was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers and distributors in the United States. The product code and lot number can be found on the individual product and shipping carton. See the table below for more information.
Baxter voluntarily sent an Urgent Drug Recall communication to all impacted customers for the impacted lot and is arranging for the return of all affected product. Customers should follow the instructions in the
Urgent Drug Recall letter to return the affected product. Customers with questions regarding this recall should contact Baxter Healthcare Center for Service at (888)-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Contacting Baxter Product Surveillance at the Baxter product feedback portal at https://productfeedback.baxter.com or emailing Baxter at corporate_product_complaints_round_lake@baxter.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. No members of BeneCard PBF were affected by this recall. Source: FDA
By Elana Gotkine, HealthDay Reporter; Medically reviewed by Carmen Pope, BPharm.
Semaglutide products are being sold online, with products likely unregistered or unlicensed, according to a research letter published online Aug. 2 in JAMA Network Open.
Amir Reza Ashraf, Pharm.D., from the University of Pécs in Hungary, and colleagues conducted a risk assessment of semaglutide online sourcing. Websites advertising semaglutide without a prescription were cataloged in July 2023; those meeting inclusion criteria were selected for a product test buy protocol. Two 0.25mg dose prefilled pens or equivalent injection vials were ordered from each website and compared to genuine Ozempic brand 1mg semaglutide solution.
Six online vendors classified as not recommended or rogue and offering parenteral semaglutide products were included in the test buys. Three offered prefilled 0.25mg/dose semaglutide injection pens and three sold vials of lyophilized semaglutide. The researchers found that genuine Ozempic scored the full 22 points on the International Pharmaceutical Federation (FIP) checklist, while test purchased products scored 8 or 9; clear discrepancies were seen in regulatory registration information, accurate labeling, and evidence that products were likely unregistered or unlicensed. One sample had elevated endotoxin, indicating possible contamination. The presence of semaglutide was revealed in all samples, with considerably low purity levels (7 to 14 percent versus 99 percent advertised). In each sample, the measured semaglutide content substantially exceeded the labeled amount.
“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” the authors write. “Two websites evaluated were sent FDA warning letters for unlawful sale of unapproved and misbranded semaglutide.” Read full article from JAMA Network.
The FDA is warning consumers not to purchase or use certain chemical peel skin products without appropriate professional supervision due to risk of serious skin injuries.
The agency has not approved any chemical peel products, and consumers should only consider using chemical peel products under the supervision of a dermatologist or licensed and trained practitioner. Many of these chemical peel products are sold in beauty product stores and online and marketed for purposes such as acne, discoloration, wrinkles, and collagen production. They contain ingredients such as trichloroacetic acid (TCA), glycolic acid, salicylic acid and lactic acid in varying concentrations that are too high to be used safely at home without supervision by a dermatologist or other licensed and trained practitioner.
Using products that contain high concentrations of these acids may lead to serious injury from chemical burns. The concentration, number of applications, and length of time a chemical peel product is left on the skin all influence how deeply it can penetrate skin layers and potentially lead to chemical burns.
These products remove layers of skin to varying depths and may cause severe chemical burns, pain, swelling, infection, skin color changes, and disfiguring scars. These injuries may even require emergency care or specialty care from a dermatologist or surgeon.
The FDA has issued warning letters to the following companies for selling these products:
The FDA encourages health care professionals and consumers to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178. Source: FDA
FDA Approves Zunveyl for the Treatment of Alzheimer’s Disease
Alpha Cognition has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zunveyl (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer’s disease.
Zunveyl, a novel oral therapy, has a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine.
FDA Approves Erzofri for the Treatment of Schizophrenia and Schizoaffective Disorder
Luye Pharma Group announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Erzofri (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Erzofri, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S.
Antipsychotic medications are used to treat and control symptoms of schizophrenia and schizoaffective disorder, but patient adherence to antipsychotics is generally poor. The use of longacting injectable (LAI) antipsychotics is effective in improving patient adherence.
Erzofri is not approved for use in patients with dementia-related psychosis, and the safety and effectiveness of Erzofri in pediatric patients have not been established. Source: Luye Pharma Group
FDA Approves Leqselvi, an Oral JAK Inhibitor, for the Treatment of Severe Alopecia Areata
Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (FDA) approved Leqselvi (deuruxolitinib) 8mg tablets for the treatment of adults with severe alopecia areata.
The recommended dosage of Leqselvi for the treatment of severe alopecia areata is 8mg orally twice daily, with or without food.
Leqselvi is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Also, Leqselvi is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
