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.
American Diabetes Association releases year-in-review for 2010
ALEXANDRIA, Va. — The American Diabetes Association on Tuesday released its year-in-review for 2010 regarding progress being made in the diabetes field.
The organization reported that among the achievements this year was $600 million secured by Congress through a two-year reauthorization of the Special Diabetes Program, as well as a total of $34.1 million in funds that were made available by the association to support the broad spectrum of diabetes research. This funding, the American Diabetes Association said, supported 338 awards at more than 125 leading research institutions in the United States, averaging more than five published papers per currently funded investigator.
Another victory for the American Diabetes Association was the Patient Protection and Affordable Care Act, which the organization said will improve diabetics’ access to health care and that they "no longer [will face] discrimination in the insurance market because of their diabetes, and no longer [will] need to worry their insurance will be taken away from them when they need it most."
The bill, the association noted, also offers other ways to assist low- and moderate-income people with diabetes, in addition to a $15 billion fund for wellness and prevention, an authorization of the National Diabetes Prevention Program aimed at those with prediabetes and a requirement targeting menu labeling at chain restaurants.
The complete list can be accessed at Diabetes.org.