Daiichi submits Benicar/amlodipine combo
This article was originally published in Pharmaceutical Approvals Monthly
Daiichi Sankyo submits an NDA Nov. 27 for a fixed-dose combination of its angiotensin receptor blocker Benicar (olmesartan) and the calcium channel blocker amlodipine, marketed by Pfizer as Norvasc. Pfizer's patent expires in September 2007; Daiichi is planning a fall 2007 launch of the combo, which could be used alone or in combination with other antihypertensive drugs. The firm reported that in clinical trials, the combination of amlodipine and olmesartan demonstrated a significant reduction in mean blood pressure...
You may also be interested in...
DJO Global will buy Trilliant Surgical to further its ongoing expansion into the US foot and ankle market.
Ying Huang was named CEO as his predecessor came under investigation in China and as partner Janssen was getting closer to seeking US FDA approval for its lead CAR-T therapy.
In addition to agreeing to emergency use of the Oxford University/Astra Zeneca and Sinovac vaccines, Brazil's medicines regulator has also published good manufacturing practices certificates for Pfizer and Janssen vaccine. It has questions about the Sputnik V authorization request.