Alimera Sciences, an ophthalmic pharmaceutical company founded just three years ago, said the FDA approved an Rx-to-OTC switch new drug application for its ophthalmic solution Alaway (ketotifen fumarate ophthalmic solution 0.025%).
Merck announced the trademark Janumet for MK-0431A, the company's investigational oral medicine combining sitagliptin phosphate with metformin for type 2 diabetes. Merck expects FDA action on the New Drug Application for MK-0431A by the end of March 2007.
Pfizer plans to establish a multi-national Expanded Access Program (EAP) to make the investigational CCR5 antagonist maraviroc, currently in ongoing Phase III clinical trials, available to HIV/AIDS patients with CCR5-tropic HIV-1 who have limited or no approved treatment options due to resistance or intolerance. Pending regulatory review and approvals of the EAP study protocol, the program will begin enrolling patients in the next few months, with a target to enroll patients from over 30 countries, Pfizer said.