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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.
AMCP calls on Congress for prohibition of generic exclusion agreementsThe 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 approves first generic Suboxone for maintenance treatment of opioid drug dependenceFDA 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.
New Products for Pharmacists- Rx, OTC, and generics (February 2013)A survey of new Rx, new generic, and new OTC products
New Products for Pharmacists: Rx and generics (January 2013)A survey of new Rx and generic products