The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.
Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.
Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.
The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.