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FDAs Gesture for Firm Manufacturing Drug for Cushings Syndrome

Act of January 1983 ("ODA"), a federal law concerning rare diseases ( or orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States, prevailing in less than 5 per 10,000 in the community.

Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions and marketing exclusivity on that drug for an extended time (seven years post-approval).

The concept behind the ODA is that the longer period of exclusivity will encourage more companies to invest money in research. Under the act many drugs have been developed, including drugs to treat such diseases as multiple myeloma, bone marrow cancer.

Welcoming the FDA decision, Corcept said it was yet to finalise its strategies for Corlux but would start going about marketing the drug soon.


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