U.S. FOOD AND DRUG ADMINISTRATION


Associated tags: Food, FDA, Safety, Pharmaceutical industry, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, Dietary supplement, Patient, Vaccine

Locations: MASSACHUSETTS, CHINA, AMERICAS, DISTRICT OF COLUMBIA, AUSTRIA, AFRICA, RARE, ECUADOR, LOS ANGELES, EGG, MARYLAND, NORTH AMERICA, PENNSYLVANIA, PHILIPS, CALIFORNIA, UNITED STATES

FDA Roundup: April 26, 2024

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Friday, April 26, 2024
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On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.

Key Points: 
  • On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.
  • The FDA expects this firm to fully address the violations described in the warning letter.
  • This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs.
  • This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions.

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

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Wednesday, April 24, 2024
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SILVER SPRING, Md., April 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

Key Points: 
  • SILVER SPRING, Md., April 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
  • "The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs."
  • Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract.
  • Approximately one-half of all women experience at least one UTI in their lifetime.

FDA Announces Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

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Tuesday, April 9, 2024
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SILVER SPRING, Md., April 9, 2024 /PRNewswire/ -- Today, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America LLC ("Philips Respironics"), Respironics California LLC, and Philips Holding USA Inc., and Roy Jakobs, CEO of Royal Philips, along with several other individual defendants named in the decree. The consent decree, with limited exceptions, restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the United States until certain requirements are met. CPAP and BiPAP machines are sleep therapy devices used for the treatment of obstructive sleep apnea. The decree also requires implementation of a Recall Remediation Plan, agreed to by the FDA and Philips Respironics, to help ensure relief is provided to patients impacted by Philips Respironics' June 2021 recall of certain ventilators, CPAP and BiPAP machines, by way of receiving a new or reworked/remediated device or, for certain devices, providing the option for a partial refund.

Key Points: 
  • The consent decree , with limited exceptions, restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the United States until certain requirements are met.
  • CPAP and BiPAP machines are sleep therapy devices used for the treatment of obstructive sleep apnea.
  • This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree."
  • The consent decree comes after Philips Respironics recalled certain ventilators, CPAP and BiPAP machines in June 2021 because of potential health risks—impacting 15 million devices worldwide.

FDA Roundup: April 9, 2024

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Tuesday, April 9, 2024
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The system includes the use of a motion scaling function, which scales down the surgeon's movements.

Key Points: 
  • The system includes the use of a motion scaling function, which scales down the surgeon's movements.
  • Microsurgery covers procedures involving the use of microscopes and small instruments to perform small-scale surgical techniques.
  • The system is intended for use by trained physicians in the operating environments described in the device's labeling.
  • On Friday, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

FDA Approves New Antibiotic for Three Different Uses

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Wednesday, April 3, 2024
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"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

What You Need to Know About Egg Safety

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Tuesday, March 26, 2024
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SILVER SPRING, Md., March 26, 2024 /PRNewswire/ -- It is important to keep food safety in mind when handling eggs.

Key Points: 

FDA Roundup: March 22, 2024

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Friday, March 22, 2024
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On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.

Key Points: 
  • On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.
  • From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA granted 933 Breakthrough Devices designations and authorized 95 Breakthrough Devices for marketing.
  • On Thursday, the FDA approved safety labeling changes for fluorouracil injection products.
  • These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances.

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

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Thursday, March 21, 2024
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SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.

Key Points: 
  • SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.
  • Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.
  • "This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation."
  • DMD is the most common childhood form of muscular dystrophy and typically affects males.

FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy

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Monday, March 18, 2024
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Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system.

Key Points: 
  • Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system.
  • The stem cells are collected from the patient and modified by adding a functional copy of the ARSA gene.
  • In children with MLD, treatment with Lenmeldy significantly reduced the risk of severe motor impairment or death compared with untreated children.
  • Eighty five percent of the children treated had normal language and performance IQ scores, which has not been reported in untreated children.

FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease

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Thursday, March 14, 2024
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NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction.

Key Points: 
  • NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction.
  • Rezdiffra is a partial activator of a thyroid hormone receptor; activation of this receptor by Rezdiffra in the liver reduces liver fat accumulation.
  • To enroll in the trial, patients needed to have a liver biopsy showing inflammation due to NASH with moderate or advanced liver scarring.
  • Patients should stop using Rezdiffra if they develop signs or symptoms of worsening liver function while on Rezdiffra treatment.