June 21, 2011

The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

June 21, 2011

The Department of Health and Human Services on Tuesday morning unveiled the nine graphic health warnings mandated by the Food and Drug Administration to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

June 20, 2011

The Food and Drug Administration has approved a new formulation of an injectable drug made by Abbott for prostate cancer.

June 20, 2011

A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

June 20, 2011

Just after the approval of their new treatment for Type 2 diabetes, Eli Lilly and Boehringer Ingelheim plan to present data in more than two dozen presentations at the American Diabetes Association Scientific Sessions starting this week.

June 20, 2011

Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.

June 20, 2011

Last month, the Food and Drug Administration approved Tradjenta (linagliptin), an oral Type 2 diabetes drug made by German drug maker Boehringer Ingelheim and Indianapolis-based Eli Lilly. The drug belongs to the class known as dipeptidyl peptidase-4 inhibitors, which also includes Merck’s Januvia (sitagliptin). With diabetes affecting some 26 million Americans and growing rapidly, Drug Store News spoke with Wa’el Hashad, BI’s VP cardiovascular and metabolic disorders marketing, about what the approval of Tradjenta means for the diabetes market.


June 20, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

June 17, 2011

A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

June 17, 2011

The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

June 17, 2011

The Food and Drug Administration has approved a drug for arthritis made by Watson Pharmaceuticals, Watson said Friday.

June 16, 2011

The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

June 15, 2011

The Food and Drug Administration has issued a warning letter to Dr. Reddy’s Labs’ chemical manufacturing plant in Mexico, the company said Tuesday.

June 15, 2011

A new oral medication for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim has become available in pharmacies, the companies said Wednesday.

June 15, 2011

Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug for eye disease, the company said Tuesday.

June 15, 2011

One month after the observance of Skin Cancer Awareness Month, the Food and Drug Administration announced Tuesday it is taking measures to assure all sunscreen products are safe and effective.

June 14, 2011

The Food and Drug Administration has approved two cough-cold medications made by Cypress Pharmaceutical, the company said Monday.

June 14, 2011

ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.

June 14, 2011

The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

June 13, 2011

The Food and Drug Administration has approved a new drug for epilepsy made by GlaxoSmithKline and Valeant Pharmaceuticals International, the drug makers said Monday.

June 13, 2011

The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

June 9, 2011

Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.

June 9, 2011

The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.