Public health agency the US Food and Drug Administration stated on Tuesday that it has authorised the new generic version of Diovan (valsartan) for the treatment of high blood pressure and heart failure.
This US FDA approval of the new generic of Diovan was awarded to Alkem Laboratories Limited.
In connection with the approval, the US FDA prioritised the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities. Not all ARB medicines have been recalled. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.
Following the assessment and evaluation of the company's manufacturing processes and appropriate testing methods, the US FDA concluded that the approved valsartan product does not contain NDMA or NDEA and there is no known risk for the formation of other nitrosamine impurities.
According to the National Heart, Lung, and Blood Institute, high blood pressure is a common disease in which blood flows through blood vessels, or arteries, at higher than normal pressures. Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs.
CivicaScript launches droxidopa for symptomatic neurogenic orthostatic hypotension
Padagis' Naloxone HCl Nasal Spray 4 mg obtains extended shelf-life of 36 months
ANI Pharmaceuticals announces US launch of Nitazoxanide Tablets
Newbury Pharmaceuticals secures approval for Macitentan in Denmark
Mallinckrodt and Endo to merge in USD6.7bn deal to create pharmaceutical leader
Genomma Lab Internacional announces quarterly dividend
Aveva Drug Delivery systems introduces generic Fentanyl Transdermal Patch in US
Independent Pharmacy Cooperative signs cooperation agreement with Legacy Pharmacy Group
ILIKOS Consulting partners with Jordan Center for Pharmaceutical Research
Axsome Therapeutics settles patent litigation with Teva over AUVELITY
Breckenridge Pharmaceutical's Everolimus Tablets for Oral Suspension receive US FDA approval
Newbury Pharmaceuticals secures generic approval for pomalidomide in Denmark
Newbury Pharmaceuticals secures generic approval for Bosutinib in Norway
Guangzhou Fermion Technology partners with Simcere Pharmaceutical