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January 8, 2013

The Food and Drug Administration on Tuesday advised consumers not to purchase or use “MAXILOSS Weight Advanced” — a product promoted and sold for weight loss on various web sites, including DreamLifeWeightLoss.com, and in some retail stores.

January 4, 2013

The Food and Drug Administration has approved a new means of administration for a multiple sclerosis drug, the manufacturers said.

January 3, 2013

The Food and Drug Administration has approved a generic drug for heavy menstrual bleeding made by Watson Pharmaceuticals, the drug maker said.

January 2, 2013

In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years.

January 2, 2013

Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets and rizatriptan benzoate tablets, generic versions of Merck's Maxalt MLT Tablets and Maxalt Tablets.

December 28, 2012

Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

December 27, 2012

The Food and Drug Administration on Monday approved Aegerion Pharmaceuticals' cholesterol drug, Juxtapid.

December 21, 2012

The Food and Drug Administration has approved a drug to treat a condition that affects people who have had their intestines partially or completely removed, the agency said Friday.

December 21, 2012

The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.

December 20, 2012

An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public's health and safety at risk.

December 19, 2012

A single lot of a congestion-relief product has been recalled due to bacterial contamination found in a sample, the Food and Drug Administration said Wednesday.

December 18, 2012

The Food and Drug Administration has approved two generic versions of a drug to treat HIV, according to agency records.

December 18, 2012

The Food and Drug Administration has approved a generic malaria drug made by Mylan, the drug maker said Tuesday.

December 17, 2012

The consumer products division of British drug maker GlaxoSmithKline wants its voice heard at a Food and Drug Administration hearing scheduled for next year on a section in a 2009 law to regulate tobacco products that deals with smoking-cessation products, the company said Monday.

December 14, 2012

The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said.

December 13, 2012

GlaxoSmithKline Consumer Healthcare and TV personality Samantha Harris have teamed up to announce the launch of "Let's Fight Holiday Fat" — a new, free online guide that provides weight maintenance support for Americans trying to squeeze in healthy eating and exercise this season.

December 12, 2012

The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

December 12, 2012

A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

December 11, 2012

The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said.

December 11, 2012

The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

December 10, 2012

The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

December 7, 2012

The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

December 4, 2012

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

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