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Launch of Generic Xeloda® Tablets in the US
Launch of Generic Xeloda® Tablets in the US.
About this update from Hikma Pharmaceuticals Plc
[{"type":"text","content":"\n \nRNS Number : 6564E Hikma Pharmaceuticals Plc 20 July 2016 \n\nHikma announces launch of Generic Xeloda® Tablets 150 mg and 500 mg in the US\n \nLondon, 20 July 2016 - Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, today announces that its wholly owned U.S. affiliate, West-Ward Pharmaceuticals Corp. (West-Ward), has launched Capecitabine Tablets 150 mg and 500 mg, the generic equivalents to Xeloda®1 Tablets. West-Ward's Capecitabine Tablets are indicated for adjuvant treatment in patients with Dukes' C colon cancer, as monotherapy in metastatic colorectal cancer, and in combination with docetaxel or as monotherapy in patients with metastatic breast cancer. \n \nAccording to IMS Health, US sales of Capecitabine Tablets 150 mg and 500 mg were approximately $493 million for the 12 months ending May 2016.\n \nSaid Darwazah, Chairman and CEO of Hikma said, \"We are very pleased to have this product approval from the Columbus portfolio. We have an excellent pipeline of differentiated products and proven R&D, supply chain and operational capabilities that we expect will drive accelerated and sustainable future growth.\"\n \n \nImportant safety information\n \nPatients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important capecitabine-warfarin drug interaction was demonstrated in a clinical pharmacology trial. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Post-marketing reports have shown clinically significant increases in prothrombin time and INR in patients who were stabilised on anticoagulants at the time capecitabine was introduced. These events occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within 1 month after stopping capecitabine. These events occurred in patients with and without liver metastases. Age greater than ...