FDA Approvals - Xeloda gets extended labelling for colorectal cancer (PharmaBiz) Roche said
Xeloda gets extended labelling for colorectal cancer (PharmaBiz)
Roche said it received positive recommendations for the marketing authorisation extensions for its anti-angiogenic agent Avastin (bevacizumab) and oral chemotherapy Xeloda (capecitabine) from the European Committee for Medicinal Products for Human Use (CHMP).
IMPAX Announces FDA Acceptance of ANDA for Generic Version of Opana(R) ER (wallstreet:online AG)
IMPAX Laboratories, Inc. (7882;OTC:IPXL) today announced that its Abbreviated New Drug Application (ANDA)
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.