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.
Teva, APP develop generic Gemzar
JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.
Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.
Under the agreement, APP will manufacture the drug, while Teva will market it. Teva was the first company to win approval for a generic version of Gemzar, entitling it to 180 days of market exclusivity in which to compete directly with the branded version.