Content about Regulatory and Washington

June 14, 2011

One week after the Senate failed to pass an amendment that would have delayed swipe-fee reform for an additional 12 months, the Department of Justice Antitrust Division reportedly is addressing anticompetitive practices related to credit cards.

June 14, 2011

ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.

June 14, 2011

The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

June 14, 2011

Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

June 14, 2011

The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

June 13, 2011

The Food and Drug Administration has approved a new drug for epilepsy made by GlaxoSmithKline and Valeant Pharmaceuticals International, the drug makers said Monday.

June 13, 2011

The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

June 13, 2011

The Patient Protection and Affordable Care Act has been a bête noire among much of the Republican party since President Obama signed it into law. But as GOP presidential candidates prepared for the first official debate in Manchester, N.H., one group launched a series of ads defending it and other programs to address the nation’s health coverage gap.

June 10, 2011

A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

June 9, 2011

Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.

June 9, 2011

The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

June 9, 2011

Lexington has received clearance from the Food and Drug Administration for marketing the HairMax LaserComb Lux 9 to treat female pattern hair loss, the manufacturer has announced.

June 9, 2011

The National Advertising Division of the Council of Better Business Bureaus earlier this week recommended that New Nordic US modify or discontinue a wide range of advertising claims for the company’s Mulberry Zuccarin dietary supplement product, including claims made in testimonials.

June 8, 2011

The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

June 8, 2011

Sens. Jon Tester, D-Mont., and Bob Corker, R-Tenn., have offered an amendment to legislation that is designed to delay swipe-fee reforms.

June 8, 2011

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

June 8, 2011

The retail industry won a big victory in Washington, D.C., as the Senate defeated an amendment that proposed to delay swipe-fee reform for another 12 months.

June 7, 2011

The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

June 7, 2011

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

June 7, 2011

The Food and Drug Administration reported Tuesday that U.S. marshals seized probiotic products from UAS Labs that were being marketed as drugs.

June 7, 2011

Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.

June 7, 2011

Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

June 7, 2011

Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

June 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.

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