On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors
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Unapproved New Drugs/MisbrandedLEESAR, Inc. Fort Myers, FL. 483 issued 05/09/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/09/2025
Short Title (70 char) LEESAR, Inc. Fort Myers, FL. 483 issued 05/09/2025
FEI Number 3010166880
Firm Name LEESAR, Inc.
Record Type 483
State FL
Establishment Type Outsourcing FacilityGlobal Generic Drug Affairs
FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.Neogen Issues Voluntary Nationwide Recall of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution
LANSING, Mich. – (BUSINESS WIRE) – Neogen Corporation (NASDAQ: NEOG) is voluntarily recalling all lots within expiry of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution, for use in dogs, cats, and horses, to the veterinarian level. Neogen distributes this product, which is manufactured by a thFirst and Last Bakery, LLC Recalls First and Last Brand Tomato Sauce Products Because Of Possible Health Risk
First and Last Bakery, LLC of Hartford, CT, is recalling the following products due to a possible health risk identified by the Connecticut Department of Consumer Protection.
• First and Last Original Marinara Sauce, Tomato & Basil
• First and Last Original Traditional Pasta Sauce, Meat FlavoredElectronic Registration and Listing Compliance Program
Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL).