Content about Food and Drug Administration

August 11, 2010
CRN taps FDA's Sharfstein as annual symposium's keynote speaker

The Council for Responsible Nutrition on Thursday announced the Food and Drug Administration's principal deputy...

August 11, 2010
FDA advisory committee recommends approval for ezogabine

A Food and Drug Administration advisory committee has given a nod of approval to an...

August 11, 2010
GPhA: Banning patent settlements will cost money, not save it

The main lobbying group for the generic drug industry said federal authorities erred in projecting...

August 11, 2010
Hepatitis C treatment gets fast-track designation from FDA

An investigational drug made by Pharmasset for treating hepatitis C will get expedited review from...

August 10, 2010
Curemark gets nod to start late-stage trial for ADHD drug

The Food and Drug Administration has approved a late-stage clinical trial of a drug for...

August 10, 2010
FDA approves additional dosage for NovoSeven RT

The Food and Drug Administration has approved a new dose of a treatment for hemophilia...

August 10, 2010
FDA approves extended use of Valcyte for kidney transplant patients

The Food and Drug Administration is allowing kidney transplant patients to use a drug for...

August 5, 2010
CRN head weighs in on dietary supplement industry attack in USA Today op-ed

The Council for Responsible Nutrition’s president and CEO Steve Mister supplied the “opposing view” to...

August 5, 2010
New formulation of Taxotere gets regulatory approval

The Food and Drug Administration has approved a new formulation of a chemotherapy drug made...

August 4, 2010
Cornerstone seeks FDA approval for generic Tussionex

Generic drug maker Cornerstone Therapeutics has filed for approval of a treatment for cold symptoms,...

August 3, 2010
NPA: Consumer Reports story is 'an attack on dietary supplements'

The Natural Products Association on Wednesday challenged a Consumer Reports report in the September 2010...

August 3, 2010
WellDoc receives FDA approval for DiabetesManager System

WellDoc, a healthcare company that develops technology solutions to improve chronic disease management outcomes and...

August 2, 2010
Octapharma gets orphan drug status for Wilate

The Food and Drug Administration has given orphan drug designation to a treatment for an...

August 1, 2010
FDA approves Merz's Xeomin

The Food and Drug Administration has approved a treatment for muscle spasms and twitches....

August 1, 2010
FDA issues warning about MMS use

The Food and Drug Administration on Friday issued a warning to consumers not to take...

August 1, 2010
Sagent's generic Imitrex receives regulatory approval

The Food and Drug Administration has approved a generic injected drug made by Sagent Pharmaceuticals...

July 22, 2010
NACDS urges FDA to move carefully in risk management rules for opioids

Note to the Food and Drug Administration from the chain pharmacy industry: when it comes...

July 22, 2010
Sandoz first to receive FDA approval for Lovenox generic

The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected...

July 21, 2010
NAD scrutinizes Millenium Health's cancer benefits claim for dietary supplement

The National Advertising Division of the Council of Better Business Bureaus has recommended that Millennium...

July 21, 2010
Personal Care Products Council responds to proposed Safe Cosmetics Act of 2010

While there is a need to modernize the regulatory structure of the cosmetics industry, the...

July 20, 2010
FDA advisory committee recommends limiting use of Genentech breast cancer drug

A Food and Drug Administration advisory committee has voted to recommend limiting use of a...

July 20, 2010
FDA approves additional strengths of Actavis' generic Wellbutrin SR

Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant,...

July 20, 2010
Fera acquires rights to investigational otomycosis treatment

Fera Pharmaceuticals has acquired rights to an investigational drug for treating a rare fungal ear...

July 18, 2010
Amgen gets priority review from FDA

The Food and Drug Administration has given priority review to an application from Amgen for...

July 18, 2010
FDA accepts NDA for Eisai's Banzel

Eisai's new drug application for a drug designed as an adjunctive treatment of seizures associated...

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