Content about Food and Drug Administration

November 8, 2012
FDA accepts Merck application for insomnia drug

The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

November 8, 2012
FDA panel recommends approval for Novartis Cushing's disease drug

A Food and Drug Administration expert panel has voted unanimously in favor of approval for a Novartis drug for a rare endocrine disorder.

November 7, 2012
FDA issues warning letter to company making illegal claims in support of light therapy device

The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

November 6, 2012
FDA approves Pfizer rheumatoid arthritis drug

The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.

November 5, 2012
Dieters still hungry for weight-loss products

The opportunity for weight loss certainly hasn’t gone away — sales of diet-aid liquids were up 12.8% to $1.2 billion for the 52 weeks ended Sept. 9 across food, drug and mass (excluding Walmart), according to SymphonyIRI.

November 5, 2012
FDA approves J&J anti-clotting drug

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

November 5, 2012
mHealth transforming health care with apps

Whatever dazzling visions science fiction may offer of the widgets of the future, the long, uphill road of technology inevitably leads to the smaller and the simpler.

November 5, 2012
NewsBytes — Chain Pharmacy, 11/5/12

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

November 5, 2012
ReportersNotebook — Chain Pharmacy, 11/5/12

Pharmacy automation manufacturer Kirby Lester has launched a version of one of its tablet counters with streamlined verification software.

November 5, 2012
Watson-Actavis latest among generic M&As

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis.

November 2, 2012
GDUFA-style user fees provide one possible source of funding for FDA compounding regulations

Given the extent of the meningitis outbreak linked to a compounding pharmacy in Massachusetts, new regulations for such pharmacies might be a good idea, but how to implement them remains uncertain.

(THE NEWS: Meningitis outbreak linked to compounding pharmacy spawns new proposed legislation. Click here to read the story.)

November 2, 2012
Meningitis outbreak linked to compounding pharmacy spawns new proposed legislation

Rep. Edward Markey, D-Mass., on Thursday announced plans to introduce legislation that would strengthen federal regulations of compounding pharmacies.

November 1, 2012
Reports: Generic extended-release drugs to get more attention from FDA

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

October 31, 2012
Sandoz starts phase-3 trial of biosimilar anemia drug

Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

October 29, 2012
Vast majority of online pharmacies are fly-by-night operations, report finds

About 97% of online pharmacies are "rogue" operations operating outside U.S. laws and regulations, according to a new report.

October 29, 2012
Watson launches generic version of Actos

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

October 26, 2012
FDA approves Teva's Synribo for blood and bone marrow cancer

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

October 26, 2012
FDA cracks down on violators of dietary supplement regulations

The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations.

October 26, 2012
FDA: Contamination found at Mass. compounding pharmacy linked to meningitis deaths

The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.

October 25, 2012
FDA approves Par leukemia drug

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

October 25, 2012
FDA declines approval of United Therapeutics PAH drug

The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

October 24, 2012
Mylan hopes to stop Watson launch of diabetes drug

Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

October 23, 2012
Federal court orders FDA to allow Watson diabetes drug launch

A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

October 23, 2012
United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

October 22, 2012
FDA approves Eisai's Fycompa for epilepsy

The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

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