BioSpecifics Systems XIAFLEX receives marketing authorization from FDA BioSpecifics Systems Corp.

Auxilium Pharmaceuticals, Inc. Has certified the privileges to XIAFLEX from BioSpecifics for three scientific indications: Dupuytren’s disease; Peyronie’s disease; and frozen shoulder . Auxilium filed its BLA for XIAFLEX for the treating Dupuytren’s disease on February 27, 2009 and received a target date beneath the Prescription Drug Consumer Fee Act time of August 28, 2009, which includes not been updated.. BioSpecifics Systems’ XIAFLEX receives marketing authorization from FDA BioSpecifics Systems Corp. , a biopharmaceutical organization developing first-in-class collagenase-based items, announced that the Arthritis Advisory Committee appointed by the U today.S.The Boxed Warning will now be added to an older class of drugs known as typical antipsychotics. The caution for both classes of drugs will say that clinical studies indicate that antipsychotic medicines of both types are connected with an increased risk of death when used in elderly individuals treated for dementia-related psychosis. It is necessary that health care professionals and consumers have got the most up-to-date drug safety details, said Thomas Laughren, M.D., director of the FDA’s Division of Psychiatry Products in the guts for Drug Evaluation and Research.