Enforcement Report - Week of April 12, 2023
Enforcement Report - Week of March 8, 2023
JB Pharma on Wednesday said it has acquired cardiac brand Razel (rosuvastatin) for India and Nepal region from Glenmark for Rs 314 crore in an all-cash deal. The acquisition will be funded through long-term debt and internal accruals, the KKR-backed company said in a statement.
On June 2, 2022, the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter [1] to Althera Pharmaceuticals, LLC (Althera) relating to promotional communication for ROSZET® (rosuvastatin and ezetimibe) tablets for oral use (Roszet). The promotional communication was a professional “Roszet Doctor Info Letter Size”. [2] This is the third untitled letter from OPDP this year. In January, OPDP sent an untitled letter to Eli Lilly & Company regarding promotional claims for TRULICITY® on social media. In March, OPDP sent an untitled letter—which we covered in our blog post here —to Bausch Health Companies for misleading statements for DUOBRII™ conveyed in a promotional video and healthcare professional website.
The FDA’s Office of Prescription Drug Promotion slapped its 3rd untitled letter of the year onto New Jersey-based Althera Pharmaceuticals earlier this month, with the agency saying the firm’s DTC ad created a misleading impression about the safety profile of its cholesterol drug Roszet (rosuvastatin and ezetimibe) and combined study results in an unorthodox way.
MORRISTOWN, NEW JERSEY, UNITED STATES, November 15, 2021 /EINPresswire.com/n-- Significantly more patients with coronary heart disease had their nbad cholesterol controlled to below 70 mg/dL on ezetimibe-rosuvastatin n10 mg-40 mg vs. highest dose (40 mg) of rosuvastatin.
Class 4 Medicines Defect Information:Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets
Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary non-familial hyperlipidemia and in adult patients with homozygous familial hypercholesterolemia. Roszet contains rosuvastatin, a powerful statin for LDL-C reduction, and ezetimibe, an efficacious cholesterol absorption inhibitor. The two components work through distinct but complimentary mechanisms to give Roszet the power to significantly lower LDL-C.
Crestor (rosuvastatin) is indicated for the treatment of dyslipidaemia and hypercholesterolaemia and is used to prevent cardiovascular disease in these high-risk populations.