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FDA drug approvals: January 2014FDA approvals, complete response, fast-track designations, priority review, first-time generic approval
CVS Caremark and Cardinal Health team up to supply generic drugsCVS Caremark and Cardinal Health are about to become the single biggest supplier of generic drugs in the United States.
FDA approves first generic versions of Aciphex delayed-release tablets to treat GERDFDA has approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (aged 12 years and up).
Do pay-for-delay agreements buy antitrust uncertainty?Agreements must be judged by antitrust’s rule of reason to determine true consequences.
First generic capecitabine approved for colorectal and breast cancersFDA 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.
Drug trend curves down while members pay moreThe 2012 drug trend declined 3.5% but members are paying three to five times more in overall healthcare costs
FDA denies request to block generic versions of Opana ERFDA 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).
Supreme Court will define generic drugmakers' liabilityFederal law does not allow generic pharma companies to deviate from brand formula.
Novartis disappointed by loss of India patent case for GlivecOn 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.
Unlock the right combination of generic, branded topical preparations to maximize efficacyContrary to popular belief, not all generic and branded topical preparations are created equal in terms of efficacy and tolerability, in part due to the crucial differences in the vehicle used.