Content about Food and Drug Administration

July 18, 2010
GMP standards will supplement the reputation of a regulated industry

For the first time in years, it seems that the dietary supplement industry will be...

July 18, 2010
Mylan gets green light for generic hypertension treatment

Mylan subsidiary Mylan Technologies has received final approval from the Food and Drug Administration for...

July 15, 2010
FDA advisory committee shoots down Vivus' Qnexa

The possibility of a new drug for treating obesity suffered a setback Thursday as a...

July 15, 2010
Personal Care Products Council supports expanded FDA role in industry oversight

The Personal Care Products Council announced on July 15 that it is calling for a...

July 14, 2010
Joint FDA advisory committee weighs in on fate of Avandia

A joint advisory committee of the Food and Drug Administration has voted to recommend allowing...

July 14, 2010
Keryx gets orphan-drug designation for neuroblastoma treatment

The Food and Drug Administration has given special designation to an investigational treatment for a...

July 13, 2010
Datamonitor: Oral drugs set to dominate MS market by 2014

The market for multiple sclerosis drugs, long dominated by biologics and injectables, soon could see...

July 13, 2010
FDA: Qualaquin has serious side effects

Unapproved use of a drug used to treat malaria can cause serious side effects, prompting...

July 13, 2010
Mylan's generic arthritis drug receives FDA approval

The Food and Drug Administration has approved a generic arthritis treatment made by Mylan, the...

July 12, 2010
Watson seeks FDA approval for generic Renvela, confirms patent challenge

Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of...

July 11, 2010
Misrepresented hand-sanitizing gel seized by federal government

The Food and Drug Administration ordered the seizure of $230,000 in hand-sanitizing gel last week,...

July 11, 2010
Sprycel receives priority review from FDA

A cancer drug made by Bristol-Myers Squibb and Otsuka Pharmaceutical has received priority review from...

July 8, 2010
FDA issues warning about Que She weight-loss supplement

The Food and Drug Administration on Thursday warned that Que She, marketed as an herbal...

July 6, 2010
Caraco begins shipment of generic Optivar

Generic drug maker Caraco Pharmaceutical Labs has begun shipping azelastine ophthalmic solution in the 0.05%...

July 6, 2010
FDA approves expanded use of Daytrana

The Food and Drug Administration has approved a drug made by Shire for treating attention...

July 5, 2010
FDA approves Purdue Pharma's analgesic

Purdue Pharma has received approval from the Food and Drug Administration for its analgesic product...

July 5, 2010
Fougera's generic Differin gets green light from FDA

The Food and Drug Administration has approved a topical drug for acne made by E....

July 5, 2010
Impax challenges Renvela patent

Generic drug maker Impax Labs is challenging the patent on a drug used to treat...

July 5, 2010
Strativa's Zuplenz receives FDA approval

The Food and Drug Administration has approved a preventive treatment made by Strativa Pharmaceuticals for...

July 5, 2010
Watson receives regulatory approval for generic Prograf

The Food and Drug Administration has approved a drug made by Watson Pharmaceuticals for treating...

June 30, 2010
Endo resubmits application for approval for Fortesta

Endo Pharmaceuticals has resubmitted its application to the Food and Drug Administration for a testosterone...

June 29, 2010
Court upholds Crestor patent

The U.S. District Court for the District of Delaware has upheld the patent on a...

June 28, 2010
Teva's generic Effexor XR receives regulatory approval

The Food and Drug Administration has approved the first generic version of an extended-release antidepressant...

June 24, 2010
CRN: Dietary supplement manufacturers must be GMP-compliant

The Council for Responsible Nutrition on Friday noted that all dietary supplement manufacturers without exception...

June 24, 2010
Dietary supplement industry gets its due with GMP requirements

The dietary supplement industry is free at last from any major news organization making any...

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