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Remicade, formerly known as Avakine, was approved by the Food and Drug Administration (FDA) on August 24.
The Plaintiffs have alleged that Defendants made false and misleading public statements concerning the signing of an European marketing partner for Remicade, formerly known as Avakine, in the fourth quarter of 1997 and its corresponding positive effect on the financial results of the Company, which artificially inflated the market price of the common stock during the Class Period and caused damage to Plaintiffs and the Class, in violation of the Securities Exchange Act of 1934.
Japan and portions of the Far East, for Avakine in Crohn's disease and rheumatoid arthritis.
Centocor has been notified by the FDA that its Biologics License Application for Avakine in Crohn's disease, filed December 30, 1997, has been accepted and will receive a priority review, and that the FDA's Gastrointestinal Drugs Advisory Committee will discuss Avakine on May 28 at 9:00 a.
Additionally, Centocor has been notified by the FDA that the Avakine BLA will receive a priority review.
We are pleased by the FDA's decision and look forward to working with the Agency to bring Avakine to market through the priority review process," said Joseph C.
Holveck cited the FDA filing for Avakine in Crohn's disease, expanded labeling for ReoPro and the continued progress shown in clinical trials with ReoPro for expanded indications in acute coronary syndromes and for Avakine in rheumatoid arthritis.
More than 400 patients treated with Avakine will be followed for 30 weeks to determine their response according to the ACR index.
international marketing rights for Avakine, however, earnings for 1997
License Application (BLA) for Avakine for the treatment of a subset of
In a 26-week trial, conducted with 101 patients, 60-70% of patients receiving 1, 3 or 10 mg/kg of Avakine with methotrexate and 3 or 10 mg/kg of Avakine without methotrexate achieved a clinical response (20% Paulus criteria), which was sustained during the 14-week treatment period (range of p-values vs.
article on the treatment of Crohn's disease with Avakine (formerly referred to as cA2 or CenTNF), which concluded that "a single infusion .