FDA approval was subject to several post-marketing commitments, including conducting and submitting data from a new long-term maintenance (relapse prevention) study, a sexual dysfunction study, pediatric studies and
The company’s Singapore facility will be located in Science Park, and is scheduled to open in early 2009. The facility will be designed to support biopharmaceutical manufacturing, continuing
The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared to placebo for the prevention of PONV.
The applications follow the successful completion of a pivotal Phase III study, in which degarelix, a new GnRH receptor blocker, was studied for the speed of the suppression
Under the agreement, Devor has been granted the exclusive right to distribute ABMC’s Rapid STAT oral fluid drug test and Rapid TOX Cup urine based drug test in
With this trial fully enrolled and the final patients undergoing dosing, the company expects to be able to announce top line results in the second quarter of 2008,
In its letter, the FDA has said that it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed
The patent had been challenged by generics manufacturer Ranbaxy and expires in July 2010. The decision has no commercial impact because company’s basic patent covering Lipitor remains in
Irinotecan hydrochloride is a generic version of Pfizer’s chemotherapy agent, Camptosar injection 20mg/mL. Shipment of this product, available in 40mg/2mL and 100mg/5mL single dose vials, will begin immediately.
The FDA has also approved a new 10mg dose formulation of Nexium for delayed-release oral suspension for use in children one to 11 years old and the product
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.