FDA has approved the oral chemotherapy tablet capecitabine, the first generic version of Teva’s Xeloda, to treat cancer of the colon or rectum that has spread to other parts of the body. It also approved generic capecitabine for treatment of metastatic breast cancer.
FDA has denied Endo Health Solutions' petition to block generic forms of its opioid agonist Opana ER, which contains oxymorphone. FDA’s decision comes just weeks after it nixed generic OxyContin and approved abuse-deterrent labeling for reformulated OxyContin (Purdue Pharma).
On April 1, the Indian Supreme Court denied Novartis’ appeal challenging the rejection of a patent for its cancer drug Glivec (imatinib mesylate), which has been patented in almost 40 countries including China, Russia, and Taiwan. This landmark ruling ends a 7-year legal battle by Novartis, which never has been granted an original patent for Glivec in India. The ruling will hinder medical progress and innovation, the manufacturer said.
The Academy of Managed Care Pharmacy (AMCP) is urging US House leaders to consider a number of proposals to rein in federal spending on healthcare without compromising the popular programs of Medicare and Medicaid.
FDA has approved generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets (Amneal Pharmaceuticals), the first generic generic versions of Suboxone (Reckitt Benckiser Healthcare (UK)) sublingual tablets for maintenance treatment of opioid drug dependence.