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GSK receives complete response letter for Avodart
LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.
GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.
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FDA reaccepts approval application for Remoxy
CUPERTINO, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.
Durect announced Thursday that the FDA had accepted a resubmitted application by King Pharmaceuticals for Remoxy (oxycodone), a controlled-release painkiller designed to reduce the risks of misuse. King and Pain Therapeutics are developing the drug using Durect’s drug-delivery technology.