FDA Approvals - FDA Approves First Gout Drug For 40 Years (Medical News
FDA Approves First Gout Drug For 40 Years (Medical News Today)
The US Food and Drug Administration has given marketing approval to a new drug that lowers levels of uric acid in the blood of patients with gout: the current treatment for the condition was developed over 40 years ago. The new drug is called ULORIC (generic name febuxostat) and Takeda Pharmaceuticals North America is the sole developer and marketer of the product in the US.
FDA Agrees To Fast Review For Oral Drug Being Tested For MS (Medical News Today)
It was announced by the drug makers Teva Pharmaceutical Industries (Petach Tikvah, Israel) and Active Biotech (Lund, Sweden) that oral laquinimod has been designated by the U.S. Food and Drug Administration as a "Fast Track Product." This designation should expedite its future review by the FDA after the sponsor submits results of current trials now underway.
SafeStitch Medical, Inc. Announces FDA Approval to Market Its SMART DilatorTM (Centre Daily Times)
SafeStitch Medical, Inc. (OTCBB:SFES) announced that the U.S. Food and Drug Administration ( FDA ) has approved the Company s 510(k) application to begin U.S. marketing of its SMART Dilator TM , the first esophageal dilator to indicate the pressure level being applied at the esophageal stricture. Having this information should reduce the incidence of esophageal perforation a devastating ...