RAPS: FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex\'s Kaldeco

The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including popular new drugs like Stendra, Belviq, Kalydeco and Brilinta. The documents, known as bioequivalence recommendations, specifically apply to the Abbreviated New Drug Application (ANDA) process—the process by which generic drugs are approved.