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.
The FDA issues a complete response letter when it has finished reviewing an approval application, but issues remain that preclude final approval. GSK did not specify what issues the FDA had cited.
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.
King resubmitted the application in late December 2010. The FDA issued a complete response letter when approval originally was sought in December 2008. The FDA issues a complete response letter when it has completed review of an approval application, but questions remain that preclude final approval.
Rite Aid’s same-store sales get a boost
CAMP HILL, Pa. — Rite Aid on Thursday morning posted a same-store sales increase of 1.1% for the four weeks ended Jan. 22, including a 2.2% lift across the front-end and growth of 0.6% in pharmacy comparable sales.
Prescription count at comparable stores was flat compared with the prior-year period.
Total drug store sales were $1.9 billion, which is flat as compared with the same period last year. Prescription revenue accounted for 69.1% of drug store sales, and third-party prescription revenue represented 93.3% of pharmacy sales.