Content about Food and Drug Administration

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...

June 24, 2010
FDA approves OraSure Technologies’ hepatitis C test

The Food and Drug Administration has approved a new rapid blood test for detecting hepatitis...

June 23, 2010
Merck gets nod from FDA for Dulera

The Food and Drug Administration has approved a new drug by Merck for treating asthma...

June 23, 2010
Pfizer suspends tanezumab trial per FDA's request

Reports of worsening conditions among patients has led drug maker Pfizer to suspend a clinical...

June 23, 2010
Watson gets tentative approval for generic Fentora

The Food and Drug Administration has given tentative approval to Watson Pharmaceuticals for a generic...

June 22, 2010
FDA approves Lucentis for vision loss-related disease

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

June 22, 2010
FDA approves Namenda XR

The Food and Drug Administration has approved a drug made by Forest Labs and Germany-based...

June 22, 2010
Orphan drug designation for Tolera's diabetes drug

The Food and Drug Administration has granted orphan drug designation to an investigational treatment for...

June 21, 2010
Hospira gets FDA nod for generic Merrem

The Food and Drug Administration has approved a generic, injectable antibiotic....

June 21, 2010
New FDA-approved test first to detect HIV antigen, antibodies

The Food and Drug Administration has approved a new test for detecting HIV antigen and...

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