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.
According to IMS Health, US sales of Capecitabine Tablets 150 mg and 500 mg were approximately $493 million for the 12 months ending May 2016.
Said 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."
Capecitabine is contraindicated in patients with severe renal impairment, with known dihydropyrimidine dehydrogenase deficiency, or with a known hypersensitivity to capecitabine or any of its components, or 5-fluorouracil.
Patients receiving therapy with capecitabine should be monitored by a physician experienced in the use of cancer chemotherapeutic agents.