FDA Approvals - IMPAX Announces FDA Acceptance of ANDA for Generic Version of
IMPAX Announces FDA Acceptance of ANDA for Generic Version of Opana(R) ER (Business Wire via Yahoo! Finance)
HAYWARD, Calif.----IMPAX Laboratories, Inc. today announced that its Abbreviated New Drug Application for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana ER, has been deemed acceptable for filing by the U. S.
Neurologix Gene Therapy Approach To Parkinson's Disease Granted Fast Track Designation From FDA (Medical News Today)
Neurologix, Inc. (OTCBB:NRGX), a biotech company engaged in the research and development of innovative gene therapies for the brain and central nervous system, announced that the U.S. Food and Drug Administration has granted Fast Track Designation for the company's experimental gene transfer procedure for the treatment of advanced Parkinson's disease. [click link for full article]