Content about Regulatory and Washington

August 1, 2011

New guidelines that will ensure women receive preventive health services at no additional cost were announced Monday by the Department of Health and Human Services.

August 1, 2011

CytoSport recently reported its receipt of a letter from the San Francisco office of the Food and Drug Administration alerting the company to concerns about its use of the word “milk” in its Muscle Milk trade name and to questions about the language used to describe Muscle Milk to consumers.

August 1, 2011

The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

August 1, 2011

The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

August 1, 2011

Eli Lilly’s India division and Indian generic drug maker Lupin will distribute Lilly’s insulin products in India and Nepal under an agreement between the two companies announced Friday.

July 29, 2011

The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

July 29, 2011

The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.

July 29, 2011

Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

July 28, 2011

The American Pharmacists Association Foundation has created two new scholarships that will be presented at the APhA’s annual gathering next year.

July 28, 2011

Sens. Ben Cardin, D-Md., and Mike Enzi, R-Wyo., last week introduced the Medical Flexible Spending Account Improvement Act (S. 1404), a bill that would allow consumers to pay taxes on and withdraw any remaining funds in their employer-sponsored flexible spending accounts.

July 28, 2011

Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.

July 28, 2011

The National Association of Chain Drug Stores announced on Thursday that it submitted comments to the U.S. Senate Health, Education, Labor and Pensions Committee, which held a hearing Thursday titled "FDA User Fees: Advancing Public Health," outlining community pharmacy's commitment to addressing drug safety and the appropriate use of prescription medications to help improve patient health.

July 28, 2011

Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

July 27, 2011

The Patient Protection and Affordable Care Act is producing savings for state Medicaid programs that take advantage of a provision equalizing drug rebates between managed care and fee-for-service programs, according to a fact sheet released Tuesday by the Association for Community Affiliated Plans.

July 27, 2011

The Council for Responsible Nutrition on Wednesday announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will deliver the keynote address at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry on Oct. 20 in Rancho Palos Verdes, Calif.

July 26, 2011

The branded drugs division of Impax Labs has finished enrolling patients in a late-stage trial of a drug for Parkinson’s disease.

July 26, 2011

Generic drug maker Lupin is seeking approval for a generic version of a contraceptive made by Warner Chilcott, according to published reports.

July 26, 2011

Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

July 25, 2011


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.

July 25, 2011

Unilever has announced changes to its category and go-to-market structure to further support its growth plans and allow for a more efficient rollout of increasingly bigger and more scalable innovations.

July 25, 2011

The Consumer Healthcare Products Association recently issued the first piece in its “Your Health at Hand” awareness campaign with a cost analysis that found Americans can avoid approximately 50 million unnecessary visits to primary care physicians each year, resulting in $5 billion in annualized savings thanks to self-care. 


July 25, 2011

Watson Pharmaceuticals is hoping to be the first to market a generic version of a GlaxoSmithKline drug for men with an enlarged prostate, Watson said.

July 22, 2011

A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

July 22, 2011

The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

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