Content about Food and Drug Administration

January 7, 2013
Biogen Idec hopes treatment will be first advance in hemophilia B treatment in 15 years

Biogen Idec is seeking Food and Drug Administration approval for a hemophilia drug that it called the first of its kind.

January 4, 2013
FDA approves new delivery method for MS drug

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

January 3, 2013
CRN celebrates 40 years championing the dietary supplement industry

The Council for Responsible Nutrition on Thursday kicked off a year-long celebration in honor of the association’s 40th anniversary.

January 3, 2013
FDA approves Watson heavy menstrual bleeding drug

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

January 3, 2013
Ranbaxy preserves exclusivity period for generic hypertension drug

A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

January 2, 2013
FDA approves 39 new drugs in 2012, a 16-year high

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
FDA approves Bristol-Myers Squibb's Eliquis to reduce risk of stroke, blood clots

The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

January 2, 2013
FDA approves J&J drug-resistant tuberculosis treatment

The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.

January 2, 2013
FDA approves Mylan's generic Maxalt MLT tablet

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
FDA approves Mylan's generic Dilantin chewable tablets

Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

December 28, 2012
FDA approves NDA for Teva's topotecan injection

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 28, 2012
Mylan generic heart drug suit against FDA dismissed

A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

December 28, 2012
Watson confirms Velcade patent challenge

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

December 27, 2012
Aegerion receives FDA approval for cholesterol drug, with strongest warning

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

December 21, 2012
FDA approves biotech drug for reducing symptoms of severe chickenpox infection

The Food and Drug Administration has approved a new drug for reducing the severity of chickenpox symptoms, the agency said.

December 21, 2012
FDA approves new drug for short bowel syndrome

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
FDA approves Tamiflu in children younger than 1 year

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 21, 2012
Federal court rules against Endo in painkiller case

A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

December 20, 2012
Advocacy group says proposed compounding regulations would endanger public health

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

December 20, 2012
Mylan, Orion settle Parkinson's disease drug case

Generic drug maker Mylan has settled with Orion over a drug used to treat Parkinson's disease, Mylan said Thursday

December 19, 2012
Matrixx Initiatives recalls one lot of Zicam gel over contamination concerns

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
FDA approves generic HIV drug

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

December 18, 2012
FDA approves generic malaria drug

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

December 18, 2012
FDA approves GSK four-strain flu vaccine

The Food and Drug Administration has approved a new four-strain flu vaccine made by GlaxoSmithKline, the drug maker said.

December 18, 2012
Generic drug safety labels often contain incorrect information, study finds

More than two-thirds of generic drugs carry safety warning labels different from those of their branded equivalents, according to a new study.

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