December 14, 2010

The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.

December 13, 2010

The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

December 13, 2010

Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

December 13, 2010

Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

December 10, 2010

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

December 8, 2010

A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

December 7, 2010

The Food and Drug Administration has accepted for review a supplemental approval application for an arthritis drug made by Bristol-Myers Squibb, the drug maker said Monday.

December 7, 2010

PARSIPPANY, N.J. — The Food and Drug Administration is exploring the benefits associated with the long-term use of nicotine-replacement therapy products, a factor expected to both extend the amount of time a person avails themselves of the smoking-cessation therapy, as well as increase the success rates for quit attempts. 


December 7, 2010

ALEXANDRIA, Va. — Simplify, simplify.


December 7, 2010

As a Food and Drug Administration advisory committee convenes to decide whether or not to approve a new drug for treating obesity, two nonprofit groups centered on the epidemic said more means of addressing it are needed.

December 7, 2010

Supplier News — Fera Pharmaceuticals has recently launched two new topical ointments. The New York-based company has developed Ilotycin (erythromycin) and Garamycin (gentamicin) ophthalmic ointments, both for the treatment of bacterial infections of the eye. “Our goal is simple: to keep more quality healthcare choices alive for the people who need them,” company co-founder Frank DellaFera said.


December 7, 2010

The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

December 3, 2010

The Food and Drug Administration has approved a generic chemotherapy drug made by Sagent Pharmaceuticals, Sagent said Thursday.

December 1, 2010

Drug maker Savient Pharmaceuticals has begun shipping its new gout treatment to specialty distributors, the company said Tuesday.

November 30, 2010

A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

November 30, 2010

The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.

November 30, 2010

The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.

November 30, 2010

Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer's drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.

November 30, 2010

Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

November 30, 2010

The Senate on Tuesday afforded the Food and Drug Administration new powers in regulating food, according to published reports, with the passing of the FDA Food Safety Modernization Act by a vote of 73-25 (with two abstentions).

November 29, 2010

The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.

November 29, 2010

A generic drug maker announced that the Food and Drug Administration has granted tentative approval for its version of a popular antidepressant.

November 29, 2010

Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

November 24, 2010

Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.