FDA Signs Off On "Authorized" Generics; Deals Are Pro-Competitive, Agency Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is not empowered to directly regulate the timing for marketing of previously approved drug products, the agency says in response to citizen petitions from Mylan and Teva. The two companies wanted FDA to prohibit the marketing of authorized generics during a first ANDA filer's 180-day exclusivity period.