BeneCard PBF compiles the latest pharmacy news from across the web, including new drug approvals, recalls, new generic drug approvals, and more. The content is the property of the website owners, writers, and contributors.
New Drug Approvals
SPIKEVAX®
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2
August 22, 2024 – Moderna, Inc. announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above.
- Emergency Use Authorization (EUA) for the Moderna’s COVID-19 Vaccine (2024-2025 formula) was also granted for individuals 6 months through 11 years of age.
- Moderna’s updated COVID-19 vaccine targets the KP.2 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA’s decision, Moderna’s updated vaccine is expected to be available in the coming days.
SOURCE: Moderna, Inc.
LAZCLUZE™
FDA Approves Rybrevant plus Lazcluze for Patients with EGFR-Mutated Advanced Lung Cancer
August 20, 2024 – Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved Rybrevant® (amivantamab-vmjw) plus Lazcluze™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions, or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
- With this milestone, Rybrevant®plus Lazcluze™ becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib (Tagrisso®) for the first-line treatment of patients with EGFR-mutated NSCLC.
- Rybrevant®is an EGFR- and MET*– directed bispecific antibody that engages the immune system, and Lazcluze™ is a highly selective, brain-penetrant, third-generation oral EGFR TKI. Rybrevant® plus Lazcluze™ is the only regimen targeting both of the common EGFR mutations directly.
Source: Johnson & Johnson
NIKTIMVO
FDA Approves Niktimvo for the Treatment of Chronic Graft-Versus-Host Disease
August 14, 2024 – Incyte and Syndax Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved Niktimvo (axatilimab-csfr), a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40kg (88.2lbs).
- Chronic GVHD is a serious condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs.
- Chronic GVHD is a leading cause of significant morbidity and mortality after an allogeneic stem cell transplant and is estimated to develop in approximately 42% of transplant recipients, affecting approximately 17,000 patients in the U.S. Of those patients who develop chronic GVHD, nearly 50% require at least three lines of treatment, emphasizing the need for additional effective treatment options.
Source: Incyte and Syndax Pharmaceuticals
LIVDELZI
FDA Grants Accelerated Approval for Livdelzi for the Treatment of Primary Biliary Cholangitis
July 26, 2024 – 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.
Source: Sun Pharma
NEMLUVIO
FDA Approves Nemluvio for the Treatment of Adult Patients with Prurigo Nodularis
August 13, 2024 – Galderma announced the U.S. Food and Drug Administration (FDA) approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.
- Nemluvio was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA – a status reserved for medicines with the potential to significantly improve the treatment of serious conditions.
- Prurigo nodularis is an underdiagnosed neuroimmune skin disease which is estimated to affect up to 181,000 people in the United States, and is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality.
- Nemluvio specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.
Source: Galderma
YORVIPATH
FDA Approves Yorvipath for the Treatment of Hypoparathyroidism in Adults
August 12, 2024 – 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.
Source: Ascendis Pharma
neffy®
FDA Approves neffy® (epinephrine nasal spray) Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
August 09, 2024 – ARS Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved neffy® (epinephrine nasal spray) 2mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30kg (66lbs).
- The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.
- Type I allergic reactions, including those caused by food, medications, and insect bites, can lead to life-threatening anaphylaxis and result in an estimated 500,000 emergency room (ER) visits each year, with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ER.
Source: ARS Pharmaceuticals, Inc.
LYMPHIR
FDA Approves Lymphir Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
August 8, 2024 – 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 T-cells 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.
Source: Citius Pharmaceuticals, Inc.
ZURNAI
FDA Approves Zurnai Auto-Injector for the Emergency Treatment of Known or Suspected Opioid Overdose
August 7, 2024 – 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.
Source: Purdue Pharma L.P.
CREXONT
FDA Approves Crexont Extended-Release Capsules for the Treatment of Parkinson’s Disease
August 7, 2024 – Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD).
- Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets. Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses.
- There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes.
Source: Amneal Pharmaceuticals, Inc.
VORANIGO
FDA Approves Voranigo for the Treatment of Grade 2 IDH-Mutant Glioma
August 6, 2024 – Servier today announced the U.S. Food and Drug Administration (FDA) approved Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor.
- It is indicated for the treatment of:
- adult and pediatric patients 12 years and older,
- with Grade 2 astrocytoma or oligodendroglioma,
- with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
- Voranigo is available and offers glioma patients the ability to actively manage their disease with the convenience of a once-daily pill. Gliomas are types of brain cancer that can hinder normal brain function and cause a variety of symptoms. Diffuse gliomas with IDH mutations represent the most common malignant primary brain tumors diagnosed in adults younger than 50 years of age.
Source: Servier
Biosimilars
PAVBLU
FDA Approves Pavblu, a Biosimilar to Eylea
August 23, 2024 – The U.S. Food and Drug Administration (FDA) announced the approval of Pavblu (aflibercept-ayyh) 2mg injection (single-dose prefilled syringe and single-dose vial) for intravitreal administration.
- Pavblu is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Pavblu is biosimilar to the reference product Eylea, and does not have an interchangeability designation.The FDA granted Amgen, Inc. approval for Pavblu based on analytical and preclinical in vitro study data, and clinical data.
- The active ingredient in Pavblu is aflibercept. Aflibercept is a recombinant fusion protein that works by blocking vascular endothelial growth factor (VEGF) to prevent abnormal blood vessel growth within the eye, and to slow down or reduce damage to the retina and help preserve vision.
Source: FDA
ENZEEVU
FDA Approves Enzeevu, a Biosimilar to Eylea
August 12, 2024 – Sandoz has announced the US Food and Drug Administration (FDA) approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu would be interchangeable with the reference medicine, as it is currently subject to unexpired exclusivity for the first interchangeable biosimilar products.
- nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.
Source: Sandoz
Generic Drug Approvals
- Trametinib Dimethyl Sulfoxide Tablets 5mg (base) and 2mg (base)
Approved: August 6, 2024 – Novugen Pharma (USA) LLC
Treatment for: Cancer
Generic for: Mekinist - Lofexidine Hydrochloride Tablets 18mg (base)
Approved: August 20, 2024 – Indoco Remedies Ltd.
Treatment for: Opiate Withdrawal
Generic for: Lucemyra - Riluzole Oral Suspension 50mg/10mL
Approved: August 22, 2024 – Alkem Laboratories Ltd.
Treatment for: Amyotrophic Lateral Sclerosis
Generic for: Tiglutik - Methylnaltrexone Bromide Subcutaneous Solution 8mg/0.4mL and 12mg/0.6mL
Approved: August 26, 2024 – Actavis Pharma, Inc.
Treatment for: Opioid-Induced Constipation
Generic for: Relistor - Amantadine Hydrochloride Extended-Release Capsules 5mg (base)
Approved: August 26, 2024 – Zydus Pharmaceuticals (USA) Inc.
Treatment for: Parkinson’s Disease
Generic for: Gocovri
Recalls
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
August 8, 2024 – 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.
| Product Catalog Number | NDC Number | Product Description | Lot Number | Distribution Range | Expiration Date | Region Distributed |
| E8000 | 0264-7800-09 | NaCl Inj. 0.9% 1000mL – E8000 |
J2L763, J2L764 |
01.Feb.2024 – 28.Feb.2024 | 31.Mar.2025 | United States |
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 Administration.
No members of BeneCard PBF were affected by this recall.
Source: FDA
Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
August 5, 2024 – 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.
| Product Code | Product Description | Lot Number | Expiry Date | NDC Number |
| 2B0944 | Heparin Sodium in 0.9% Sodium Chloride Injection, 2,000 units per 1,000mL |
N008235 | 31-Aug-2024 | 0338-0433-04 |
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.
Any product quality complaints or adverse events experienced with the use of these products may be reported using one of the following options.
- 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 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 Administration.
No members of BeneCard PBF were affected by this recall.
Source: FDA