Enforcement Report - Week of September 6, 2023
Enforcement Report - Week of May 31, 2023
Enforcement Report - Week of July 27, 2022
Enforcement Report - Week Of June 01, 2022
DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) approval of new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections. These new Clinimix formulations contain up to 80 g/L of amino acids, the highest protein in any multi-chamber bag available in the U.S.,2 making it easier to reach patient protein targets while delivering less fluid and dextrose than provided by existing formulations.3,4
BioconNSE -0.48 % and Mylan have got a US food and drug administration nod to launch for its insulin glargine injection in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.
Enforcement Report - Week of October 30, 2019
US FDA Enforcement Report- 8/June/2016
Co-amorphization has recently been shown to be a promising approach for stabilizing amorphous drugs and improving the dissolution rate of poorly water-soluble drugs. In this study, three basic amino acids were chosen as small molecular weight excipients to interact with the drug to form co-amorphous combinations. The co-amorphous combinations of valsartan (VAL) with l-histidine, l-arginine, and l-lysine were prepared by vibrational ball milling. Solid-state characterization with X-ray powder diffraction and differential scanning calorimetry (DSC) revealed that all of the co-amorphous mixtures were homogeneous. The molecular interactions of the co-amorphous mixtures were investigated through the glass transition temperature (Tg) in the DSC measurements and Fourier transform infrared spectroscopy.
Baxter Healthcare Corp., Ongoing Class II recall of Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04 because of Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal