Alkermes receives tentative routine notification for FDA advisory committee conference on VIVITROL sNDA Alkermes, Inc. today announced that the U.S. Notification of the potential advisory committee meeting follows a designation in May 2010 by the FDA of priority review of the VIVITROL sNDA, a designation that accelerates the FDA’s focus on review timeline from ten to six months for drugs that offer major improvements in treatment or give a treatment where no sufficient therapy exists. With concern review, the Prescription Medication User Fee Work date for the FDA’s decision regarding acceptance of the VIVITROL sNDA for opioid dependence is usually October 12, 2010. An interview with Professor Lesley JonesAllergan settles patent litigation with Amneal linked to NAMENDA XR expanded launch capsulesNovo Nordisk announces FDA authorization of Tresiba for diabetes treatment’The forthcoming FDA advisory committee meeting represents progress toward our objective of obtaining acceptance of VIVITROL for individuals with opioid dependence, building on the recent concern review designation by the FDA and our compelling phase 3 pivotal data displaying the efficacy of VIVITROL for opioid dependence.The individual will most be put into the recovery room soon after the procedure likely. Many hospitals and outpatient clinics will keep the patient for an complete hour or until she is fully awake. The patient will have to request a ride home. It is suggested that the patient not really drive for at least 24 hours after anesthesia. That is recommended actually after a sedative/local anesthesia because side effects of these drugs can temporarily impair the coordination and response period. Naproxen or ibuprofen are given for rest from cramping usually. Narcotics are rarely, if ever, needed for the pain following D&C.
Albemarle, Pharmacore partner to provide manufacturing capabilities for high volume capability projects Albemarle Corporation , a leading global provider of custom manufacturing solutions, announced today it will partner with PharmaCore to provide manufacturing capabilities for customers with projects that want high volume capacity.