Company news: REMS for Purdue, Pfizer and Janssen painkillers

Share this article:
A potentially dangerous and oft-abused class of painkillers will be required to have REMS risk management programs in place under an FDA edict covering all extended release and long-acting opioid analgesics, a category covering 30 drugs manufactured by 20 companies. The agency said it had decided to require a Risk Evaluation and Mitigation Strategy of the extended-release and long-acting products but not immediate release drugs because “FDA has concluded that there is a disproportionate safety problem associated with these products that must be addressed.” The products include Purdue's OxyContin, Palladone, Butrans and MS Contin; Pfizer's Avinza and Embeda; Janssen's Duragesic and Nucynta ER; and Endo's Opana ER, among others.  

Church & Dwight Co., the maker of Trojan Brand Condoms, is sponsoring a series of HealthGuru.com videos on sexual health topics. The videos, aimed at teens and young adults, follow Healthguru's Q&A format, allowing users to engage directly with a panel of sexual health experts. “Via our partnership with HealthGuru.com, we're providing an accessible space for people to receive the information they need to make informed decisions about their sex lives and bring more pleasure into the bedroom,” said Trojan VP marketing Bruce Weiss.

The FDA approved Mumbai-based Lupin Pharmaceuticals' bid to market a generic version of Lyrica (pregabalin). The Pfizer drug was indicated for neuropathic pain associqted with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and fibromyalgia, and saw sales of around $1.8 million in the US for the year to March 2012.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Illumina inks deal with J&J, AstraZeneca, Sanofi

The goal is to develop companion diagnostics to match patients with cancer treatments.

Abbott deal highlights inversion inaction

Political furor over the recent spate of tax inversions is having little influence on how the government chooses its partners.

Allergan reported to seek out Salix deal

The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.