Posts in category: Uncategorized

FDA Grants Accelerated Approval for Livdelzi for the Treatment of Primary Biliary Cholangitis

Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) granted accelerated approval for Livdelzi(seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.

• The accelerated approval was based primarily on data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12, versus 20% of participants taking placebo.
• Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s).

Source: Gilead Sciences, Inc.

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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.

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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

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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.

Source: Alpha Cognition

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July 2024

• Indium In-111 Pentetreotide Injection Kit 3 mCi/mL
  Approved: July 1, 2024 – Sun Pharmaceutical Industries, Inc.
  Used for: Diagnosis and Investigation
  Generic for: Octreoscan
• Bupivacaine Liposome Injectable Suspension 133mg/10mL (13.3mg/mL) and 266mg/20mL
  (13.3mg/mL)
  Approved: July 1, 2024 – Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Used for: Analgesia
  Generic for: Exparel

June 2024

• Palbociclib Tablets 75mg, 100mg and 125mg
  Approved: June 5, 2024 – Synthon Pharmaceuticals, Inc.
  Treatment for: Breast Cancer
  Generic for: Ibrance Tablets
• Avanafil Tablets 50mg, 100mg and 200mg
  Approved: June 14, 2024 – Hetero Labs Limited
  Treatment for: Erectile Dysfunction
  Generic for: Stendra
• Phentermine Hydrochloride and Topiramate Extended-Release Capsules 3.75mg (base)/23mg,
  7.5mg (base)/46mg, 11.25mg (base)/69mg and 15mg (base)/92mg
  Approved: June 25, 2024 – Actavis Laboratories FL, Inc.
  Treatment for: Obesity
  Generic for: Qsymia

Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing diclofenac and omeprazole cannot be marketed as dietary supplements. UMARY is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.

Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acidrelated disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications. The product is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets. The affected product includes all lots within expiry. The product was distributed via online store Main Products, Inc. on Amazon.com.

Main Products, Inc. is notifying its customers by email and is arranging for the return of all recalled products. Consumers that have UMARY which is being recalled should stop using and return to their place of purchase. Consumers may return the products to the address below.

Main Products, Inc., 1551 Glenwood Springs Ave., Chula Vista CA, 91913
www.main-products.com.
Source: FDA

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Endo, Inc announced that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg tablets 60-count pack to the consumer level.

The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125mg and not 0.25mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25mg.

This recall impacts the following product lot:

• See below image of correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25mg 60-count carton, lot 550147301, expiration date August 2026
• See below image of incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125mg
  60-count carton, lot 550147301, expiration date August 2026

(Note: No BeneCard PBF members were affected by this recall.)
Source: FDA

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