Tags : Althera

Insights+

Insights+: The US FDA New Drug Approvals in March 2021

The US FDA has approved 7 NDAs in Mar 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 19 novel products in 2021. Additionally, last year in 2020, the US FDA has approved […]Read More

Regulatory

Althera’s Roszet (rosuvastatin and ezetimibe) Receives the US FDA’s Approval

Shots: The US FDA has approved Roszet for the treatment of elevated LDL-C in adult patients with primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia The result showed a reduction of LDL cholesterol by 72% with 40mg/10mg dose and 64% with 10 mg/10mg dose. The level of LDL-reduction indicates from both the statin component i.e rosuvastatin […]Read More