Content about Food and Drug Administration

October 3, 2010
J&J receives complete response letter for tapentadol ER

The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson...

October 3, 2010
Mylan's generic leukemia drug gets green light from FDA

The Food and Drug Administration has approved a generic chemotherapy drug made by Mylan....

October 3, 2010
Nearly $3 million for TB research awarded under FDA's Critical Path Initiative

The Food and Drug Administration has awarded almost $3 million for tuberculosis research, the agency...

October 3, 2010
Shionogi gets FDA approval for Kapvay

The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity...

September 30, 2010
FDA has eye on companies that sell oral colchicine

The Food and Drug Administration is cracking down on companies that sell an unapproved treatment...

September 30, 2010
J&J chairman addresses McNeil 'phantom recall' before House committee

McNeil products soon will repopulate shelves, Johnson & Johnson chairman and CEO Bill Weldon shared...

September 29, 2010
Centocor Ortho Biotech seeks expanded approval for Simponi

The biotech division of Johnson & Johnson is hoping to expand the use of a...

September 29, 2010
FDA tentatively approves generic Crestor

The Food and Drug Administration has given tentative approval to a generic cholesterol drug made...

September 29, 2010
Teva receives complete response letter for Neutroval

The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker...

September 28, 2010
Abbott's multipurpose disinfecting solution for contacts gets FDA OK

Abbott has received market clearance from the Food and Drug Administration for RevitaLens Ocutec, a...

September 28, 2010
Keryx commences phase-3 trial for Zerenex

Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum...

September 27, 2010
FDA: Mouth rinse products cannot have 'prevents gum disease' claim

The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture...

September 27, 2010
GSK Consumer Healthcare to FDA: Smoke out smokeless tobacco products

GlaxoSmithKline Consumer Healthcare is urging the Food and Drug Administration to remove smokeless tobacco products...

September 27, 2010
Sun Pharma gets FDA approval for ALS generic

The Food and Drug Administration has approved a generic version of a drug for a...

September 26, 2010
Biosimilars’ future predicted to be as uncontroversial as generics

Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon...

September 26, 2010
FDA approves contraceptive Beyaz

The Food and Drug Administration has approved a new oral contraceptive from Bayer HealthCare Pharmaceuticals....

September 26, 2010
GPhA and FDA to discuss me-too medicines at technical conference

More than a dozen top Food and Drug Administration officials will meet with generic drug...

September 26, 2010
In testimony, NACDS hails federal effort to simplify patient medication information

Federal efforts to simplify and standardize the information that patients receive with their prescription medications...

September 26, 2010
NACDS conference discusses patent cliff, future of generics

Winc Design is launching its Charlie Banana brand of environmentally friendly cloth diapers and baby...

September 26, 2010
Pfizer subsidiary to market authorized generics

The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone...

September 26, 2010
REPORTERS Notebook

Greenstone announced the launch of an authorized generic version of the Alzheimer’s disease drug Aricept...

September 23, 2010
AstraZeneca-Bristol drug just as effective as generic on market, trial results show

An investigational diabetes drug works as well as a generic already on the market, according...

September 22, 2010
Bionovo receives CMC approval for Menerba

The Food and Drug Administration has approved a manufacturing plan for a drug to treat...

September 22, 2010
FDA accepts approval application for AstraZeneca's vandetanib

The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug,...

September 22, 2010
FDA to allow GSK’s Avandia, with restrictions

The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes...

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