Regulatory and Washington

CHICAGO — The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

AbbVie announced the approval of the new version of AndroGel (testosterone) 1.62%, available in a packet containing 40.5 mg of testosterone in 2.5 g of gel and a packet with 20.25 mg of testosterone in 1.25 g of gel. The drug is used to raise testosterone levels in men with low or no testosterone, known as hypogonadism, estimated to affect nearly 14 million men in the United States.

KANSAS CITY, Mo. — Hostess Brands on Thursday announced that the stalking horse bid submitted by McKee Foods for the Drake's snack cake brand will be presented for approval to the U.S. Bankruptcy Court, as no other qualified bids were received for those assets.

McKee has agreed to pay $27.5 million for the Drake's brand and certain equipment. Drake's products include Ring Dings, Yodels, Devil Dogs, Yankee Doodles, Sunny Doodles and Drake's Coffee Cake.

WASHINGTON — The National Association of Chain Drug Stores (NACDS) today applauded the introduction of S. 557, the Medication Therapy Management Empowerment Act of 2013, introduced yesterday by U.S. Sens. Kay Hagan, D-N.C., and Pat Roberts, R-Kan., along with the support of original cosponsors U.S. Sens. Sherrod Brown, D-Ohio, Al Franken, D-Minn., Tim Johnson, D-S.D., and Amy Klobuchar, D-Minn. The legislation seeks to expand access to MTM services for senior citizens enrolled in the Medicare program.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday endorsed H.R. 1188, legislation introduced by U.S. Reps. Tom Marino, R-Pa., and Judy Chu, D-Calif. The bill will allow independent community pharmacies to collectively negotiate the terms and conditions of insurance contracts they must sign, typically with pharmacy benefit managers that administer prescription drug plans. 

WASHINGTON — Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

BAKERSFIELD, Calif. — Walgreens was singled out in a lawsuit earlier this week here for suggesting a vitamin E supplement may help improve cardiovascular health. 

Specifically, according to a Reuters report Monday, the complainant stated that Walgreens' Vitamin E 400 IU purported to "naturally contribute to cardiovascular health by helping to protect LDL cholesterol from oxidation which may cause cellular damage." 

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.