Regulatory and Washington

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

The George F. Archambault Scholarship, created by the Archambault Foundation, and the Charlie Thomas Scholarship, created by Phi Lambda Sigma, will be presented at the 2012 APhA Annual Meeting and Convention in New Orleans during the Contributors’ Breakfast. Phi Lambda Sigma is the national Pharmacy Leadership Society.

ALEXANDRIA, Va. — 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.

WASHINGTON — 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.

WASHINGTON — 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.

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

Impax Pharmaceuticals said Tuesday that it had enrolled patients in ASCEND-PD, a phase-3 trial of IPX066 that will compare the drug with carbidopa-levodopa and entacapone in patients with advanced Parkinson’s. IPX066 is an extended-release formulation of carbidopa-levodopa in capsule form.

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

Reuters reported that Lupin had applied for approval of a generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets), an oral contraceptive.

OSAKA, Japan — 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.

Takeda announced that it resubmitted its applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Actos, which the FDA approved in 1999.

The FDA will review the applications over the next six months, the drug maker said.


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today.