Regulatory and Washington

PRINCETON, N.J. — The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval and launch of clindamycin in 5% dextrose in minibag form, the first generic version of Pfizer's Cleocin Phosphate in Dextrose 5%.

Sales of the branded version were $52.2 million in 2012, according to IMS Health.

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.

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.

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.

FORT LAUDERDALE, Fla. — National Association of Chain Drug Stores president and CEO Steve Anderson pledged to be proactive in advocating for pharmacy in the organization's 80th year.

Speaking at the NACDS' Regional Chain Conference Monday, Anderson said pharmacy stood at an "inflection point," with many more on the horizon.