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Impax Labs pursuing FDA approval for generic cholesterol-lowering drug

BY Alaric DeArment

HAYWARD, Calif. Generic drug maker Impax Labs is hoping to win approval for a generic cholesterol-lowering drug.

Impax said it had filed an application with the Food and Drug Administration for approval of a version of Merck & Co.’s Vytorin (ezetimibe and simvastatin) in the 10 mg/80 mg strength. Vytorin had sales of around $222 million during the 12-month period ended June 30, according to Wolters Kluwer Health.

Impax’s application contained a paragraph IV certification, a legal assertion that the patents covering Vytorin are invalid, unenforceable or won’t be infringed. In response, under the provisions of the Hatch-Waxman Act of 1984, Merck subsidiaries Schering Corp. and MSP Singapore Co. filed suit for patent infringement against Impax in the U.S. District Court for the District of New Jersey. The suit puts a stay on the FDA’s approval of the drug until Impax goes to trial and wins or until the companies resolve the matter before the court.

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Industry voices support for meth act

BY DSN STAFF

WASHINGTON —The industry-supported Combat Methamphetamine Enhancement Act, H.R. 2923, passed muster at the House Committee on Energy and Commerce last month. The bipartisan bill now has moved before the full U.S. House of Representatives for approval.

The bill would require retailers to self-certify with the Drug Enforcement Administration that they comply with current safeguards. These safeguards prevent single customers from purchasing suspiciously large quantities of certain products, require distributors of these products to sell only to retailers who are registered with the DEA and establish civil fines for those who fail to comply with the regulations.

“Our membership has long supported both local and national efforts to combat methamphetamine abuse and production,” Steve Anderson, president and CEO of the National Association of Chain Drug Stores, wrote in a July 28 letter to the Committee on Energy and Commerce. “In fact, even before the introduction of state and federal legislation, the majority of the chain pharmacies took voluntary, proactive steps to reduce the theft and illegitimate use of products containing pseudoephedrine…. Moreover, our members have worked closely with DEA and state and local law enforcement officials since 1995 to stem the tide of methamphetamine production in communities across the United States.”

In addition to NACDS, the bill also is supported by the Community Anti-Drug Coalitions of America, the National Fraternal Order of Police, the Healthcare Distribution Management Association and the Consumer Healthcare Products Association.

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What’s Hot: Garnier enters no-frizz biz

BY DSN STAFF

PARIS —Many women go to great lengths to have frizz-free hair, and some even will spend hundreds of dollars for professional salon treatments. Now they can get sleek locks at home for a fraction of the price with the new Garnier Fructis Style Sleek & Shine Blow Dry Perfector.

This new two-step kit promises to smooth, de-frizz and de-bulk hair for up to seven shampoos. First, apply the Smooth-It serum to clean, damp hair, and leave it on for 20 minutes before rinsing. Then apply the Heat-Activated Perfect-It cream and blow-dry or flat-iron as usual. The results are expected to last for up to seven shampoos as hair gradually returns to its pretreatment state.

The nonpermanent styling aid works best on medium to thick hair and is safe for color-treated hair. The kit hit retail shelves in July and has a suggested retail price of $11.99.

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