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FDA approves Korlym for Cushing's syndrome
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.
The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics' Korlym (mifepristone) for endogenous Cushing's syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.
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Mylan receives tentative approval for HIV/AIDS drug in developing countries
PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.
Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.