Mylan Expects Decision On Duragesic Pediatric Exclusivity “Shortly”
This article was originally published in The Pink Sheet Daily
Executive Summary
CEO Robert Coury says Mylan is prepared to “counterbalance” any strategies by Johnson & Johnson that would prevent the firm from launching its fentanyl ANDA this year. FDA should be more concerned about the use of citizen petitions and other strategies that delay generic access, he says.
You may also be interested in...
J&J Duragesic Patent Upheld; Pediatric Exclusivity Dispute Will Determine Timing Of Mylan Generic
Mylan claims it should be able to launch in July; J&J says the generic is blocked by pediatric exclusivity until January 2005. Mylan says J&J failed to sue within statutory 45-day period and so forfeits pediatric exclusivity protection.
U.S. Patents Could Limit President's AIDS Drug Assistance Plan, GAO Says
The U.S. Global AIDS Coordinator's Office suggests it will use its authority to purchase an FDA-approved generic antiretroviral product for which permission could not be obtained from the patent holder. FDA grants tentative approval to a South African firm for a generic co-packaged version of Combivir and Viramune.
Menactra Pricing Will Be In Line With Wyeth's Prevnar, Sanofi-Aventis Says
Sanofi-Aventis will price its meningococcal conjugate vaccine Menactra in line with Wyeth's pneumococcal vaccine Prevnar
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: