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.
Watson seeks FDA approval for generic Welchol
MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.
Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.
Watson’s application included a Paragraph IV certification, a legal assertion that the patents covering Welchol are invalid, unenforceable or not vulnerable to infringement. Under the terms of the Hatch-Waxman Act of 1984, Daiichi Sankyo and Genzyme have filed suit against Watson in the U.S. District Court for the District of Delaware, putting a stay of final Food and Drug Administration approval on the drug until June 2013, or until the companies reach a settlement.
NACDS goes mobile
ALEXANDRIA, Va. — Helping on-the-go members stay updated with its latest efforts, the National Association of Chain Drug Stores has launched a mobile website.
When members access NACDS Mobile at m.NACDS.org, the “guide on the go” provides them with information about NACDS meetings, advocacy and public relations.
“NACDS Mobile applies a current approach to NACDS’ consistent mission,” NACDS president and CEO Steve Anderson said. “Wherever you are, it delivers the latest on NACDS’ work to foster business community and to advance pharmacies as the face of neighborhood health care through government advocacy and communications.”
NACDS Mobile complements the smartphone applications that were introduced for use at select NACDS meetings and conferences in 2010, and which will remain in use for select meetings in 2011.