December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

December 20, 2010

Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

December 17, 2010

The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

December 16, 2010

Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

December 15, 2010

A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.

December 15, 2010

The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.

December 15, 2010

A new Consumer Reports poll released Monday found that only one-fifth of U.S. adults were aware of having purchased food, medication or a product (other than a car) that was recalled in the past three years.

December 15, 2010

Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

December 14, 2010

The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

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.