Generics

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.

LOS ANGELES — Rx Timer Cap has introduced a new version of the cap designed for ease of use among elderly patients.

The company announced Tuesday the introduction of the new EZ-Twist removal system for making the cap easy to open and close for people who don't require childproof caps.

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.

LAKE MARY, Fla. — CueScript on Tuesday launched an innovative platform that delivers on-demand prescription-specific videos and other value-added services designed to engage patients, improve health literacy and improve medication adherence. 

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.

DUBLIN, Ohio — Cardinal Health on Tuesday posted $25.2 billion in revenue for its 2013 second quarter, down 7%. The company's non-GAAP diluted earnings per share was up 15% to $0.93. 

WOONSOCKET, R.I. — CVS Caremark is marking American Heart Month by encouraging heart-healthy behavior in February, the company said Tuesday.

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.