fda

FDA Approves ARMLUPEG (Pegfilgrastim-unne) Biosimilar

The FDA has approved ARMLUPEG (pegfilgrastim-unne), a biosimilar drug manufactured by LUPIN LTD. This approval marks the addition of a new biosimilar product to the market, following the FDA's review process.

FDA Issues Emergency Use Authorization for F10 Antiseptic Wound Spray for New World Screwworm

The FDA has issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide for the prevention and treatment of New World screwworm in multiple animal species, excluding domestic dogs and cats. This authorization allows for broader use than previously approved products, with specific food safety guidelines for treated animals.

FDA Authorizes Drugs for New World Screwworm in Dogs and Cats

The FDA has issued two Emergency Use Authorizations (EUAs) for NexGard and NexGard COMBO for the treatment of New World screwworm infestations in dogs and cats, respectively. These EUAs are effective until the HHS Secretary terminates the public health emergency declaration for this pest.

FDA Guidance on Defining Drug Use Durations for Medically Important Antimicrobials

The FDA has finalized guidance (GFI #273) recommending how animal drug sponsors can voluntarily establish defined durations of use for medically important antimicrobial drugs administered in feed to food-producing animals. Over 100 drugs are affected, and sponsors are expected to submit revised labeling within approximately three years.

FDA Issues Emergency Use Authorization for Ivomec to Prevent Screwworm in Cattle

The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution to prevent New World screwworm infestations in cattle. This authorization allows for over-the-counter use under specific conditions and is effective until the declared emergency is terminated.

FDA Approves First Generic Florfenicol and Flunixin Injection

The FDA has approved nixiFLOR, the first generic version of florfenicol and flunixin meglumine injection for treating bovine respiratory disease. This approval marks a new generic option for beef and non-lactating dairy cattle, with a withdrawal period of 38 days.

FDA Warns of Serious Risks from Unapproved Cell/Tissue Products

The FDA is warning consumers and healthcare professionals about the serious risks associated with unapproved human cell and tissue products, including patient deaths. The agency is investigating products like Laennec and reminds the public to report adverse events.

FDA Notification: Influenza Vaccine Safety Labeling Change

The FDA has notified ID Biomedical Corporation of Quebec (GlaxoSmithKline Biologicals) of a required safety labeling change for its FLULAVAL influenza vaccine. Postmarketing studies indicate an increased risk of febrile seizures in young children following vaccination, necessitating updates to the product's prescribing information.

FDA Safety Labeling Change for FluMist

The FDA has notified MedImmune, LLC of a required safety labeling change for FluMist, an influenza vaccine. The change is based on postmarketing studies indicating an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination.

FDA Safety Labeling Change for Fluzone Vaccine

The FDA has notified Sanofi Pasteur Inc. of a required safety labeling change for Fluzone vaccine. Postmarketing studies indicate an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination. This change mandates updating the 'Warnings and Precautions' section of the vaccine's labeling.