Aurobindo Pharma and Unichem Laboratories are recalling different nproducts in the US market, the world’s largest market for medicines, duento manufacturing issues. As per the latest enforcement report issued bynthe US Food and Drug Administration (FDA), Aurobindo’s US-based unit isnrecalling 7,296 containers of hypertension drug Carvedilol tablets.
Aurobindo Pharma and Unichem Laboratories are recalling different products in the US market, the world's largest market for medicines, due to manufacturing issues.
Enforcement Report - Week of September 1, 2021
Leading drug makers Dr Reddy's Laboratories and Zydus Pharma are recalling bottles of a product each, in the US market, for different reasons, according to the latest report of the US health regulator. Dr Reddy's Laboratories, Inc, the US arm of Dr Reddy's Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg, the latest enforcement report by the US Food and Drug Administration (USFDA) said.
Enforcement Report - Week of August 25, 2021
A team of researchers from Monash University has discovered that a cardiac drug (carvedilol) could greatly reduce breast cancer progression, with those taking the drug at the time of diagnosis also much more likely to survive.
The aim of this study was to investigate the amorphization, physical stability and drug release of a model drug, carvedilol (CAR), when loaded onto functionalised calcium carbonate (FCC) using mechanochemical activation (vibrational ball milling). The solid-state characteristics and physical stability of CAR–FCC samples, prepared at different weight ratios and for different milling times, were determined using differential scanning calorimetry and X-ray powder diffraction. Upon milling CAR–FCC samples containing 50% CAR, amorphization of CAR was observed after 10 min. For CAR–FCC samples milled for either 30 or 90 min, it was found that CAR was amorphised at all ratios (10–90% CAR), but FCC remained crystalline. The glass transition temperature (Tg?) of the various CAR–FCC samples milled for 90 min was found to be similar (38 °C) for all ratios containing 20% CAR and above. The similar Tg?s for the different drug ratios indicate deposition of amorphous CAR onto the surface of FCC. For CAR–FCC samples containing 10% CAR, a Tg? of 49 °C was found, which is 11 °C higher compared with other CAR–FCC samples. This may indicate restricted molecular mobility resulting from CAR molecules that are in close contact with the FCC surface.
Enforcement Report - Week of May 15, 2019
One month after a Delaware federal jury found Teva Pharmaceuticals willfully infringed a patent tied to the hypertension drug Coreg and handed GlaxoSmithKline a $235 million verdict, Teva on Friday pushed for the court to grant it judgment or a new trial, and GSK asked for enhanced damages and attorney fees.