Regulatory and Washington

HARRISBURG, Pa. — Wine and liquor next year may be available for sale in retail outlets, including pharmacy, across Pennsylvania. 

Pa. Gov. Tom Corbett on Tuesday submitted the spending plan for the 2013/2014 state budget, which includes a provision to replace the more than 600 state liquor stores with twice as many privately run liquor and wine stores, according to an AP report published Tuesday by the Patriot News. 

NEW YORK — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

ALLEGAN, Mich. — The Food and Drug Administration has approved a testosterone gel product made by Perrigo, the drug maker said Tuesday.

Perrigo announced the approval of the testosterone gel in the 1% strength for the treatment of men with low or no testosterone.

The drug is bioequivalent to AbbVie's AndroGel, which has annual sales of about $705 million, according to Symphony Health.

CHICAGO — A JAMA report released Monday afternoon that suggested a high intake of supplemental calcium is associated with an increased risk of cardiovascular disease death in men was criticized by several dietary supplement agencies for being inconclusive. According to the Council for Responsible Nutrition's most recent survey of U.S. adults, 17% indicated they take a calcium supplement.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Monday submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

NEW YORK — A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

FORT LAUDERDALE, Fla. — To put Walgreens president and CEO Greg Wasson's speech at the National Association of Chain Drug Stores' Regional Chain Conference on Monday into perspective, one may consider that pharmacists today are the leading providers of immunizations and vaccinations, whereas five years ago, they weren't involved at all.

Wasson, NACDS' current chairman, focused on the themes of innovation and engagement, citing immunizations and vaccinations as examples that "people are ready for community pharmacy to take on a greater role."