Aurobindo's Generic Valganciclovir Hydrochloride Receives Approval in the U.S.
Hetero's Generic Valganciclovir Hydrochloride Receives Approval in the U.S.
Jaslok Hospital and Research Centre, a leading multi-specialty hospital in Mumbai, is the pioneer of kidney and liver transplant in western India. A recent study helmed by Dr Madan Bahadur, director, Department of Nephrology and Kidney Transplantation, highlights a first-in-the-world medical report, that discovered life threatening side effects with certain antivirals, in patients with a genetic defect, prevalent in a subgroup of Indian transplant patients.
Airis Pharma's Generic Valganciclovir Hydrochloride Receives Approval in U.S.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the United States commercial availability of LIVTENCITY™ (maribavir), the first and only treatment for adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.1 LIVTENCITY, an orally bioavailable anti-CMV compound, became available for prescription on December 2, 2021, just over a week after the U.S. Food and Drug Administration (FDA) approval which took place on November 23, 2021.
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved LIVTENCITY™ (maribavir) for the treatment of adults and pediatric patients (12 years of age or older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet.1 Overall, more than twice the proportion of adult transplant patients with refractory or resistant (R/R) CMV infection/disease achieved confirmed CMV DNA level <LLOQ* (lower limit of quantification, i.e. <137 IU/mL) at Week 8 (end of treatment phase), the study’s primary endpoint, with LIVTENCITY (56%; n=131/235), compared to those treated with conventional antiviral therapies (24%; n=28/117) (adjusted difference: 33%, 95% CI: 23–43; p<0.001).†‡§ LIVTENCITY is Takeda’s second new molecular entity to receive FDA approval in FY2021.
The FDA’s antimicrobial drugs advisory committee on Thursday voted unanimously in favor of FDA approving Takeda’s antiviral for post-transplant cytomegalovirus.
Mylan`s Generic Valganciclovir Hydrochloride Receives Approval In US
The virus that causes COVID-19, SARS-CoV-2, cannot grow and spread through the body without the help of a protein called polymerase. Now researchers at Columbia University and the University of Wisconsin-Madison have identified several molecules that interfere with the polymerase reaction—and some of them are already FDA-approved to treat other viruses.