FDA update on generic drugs for February 4, 2009

[chantell.reagan]

FDA update on generic drugs for February 4, 2009:

Lamotrigine 2mg chewable tablets (AB rated generic* for Lamictal) by various manufacturers

Risperidone 1mg/ml solution (AA rated generic* for Risperdal) by Teva
(Of note, Teva has been awarded a 180-day period of marketing exclusivity, as the first company to file an ANDA containing a paragraph IV certification for this product)

* The key to the FDA’s Therapeutic Equivalence Evaluation Codes is available at: Orange Book Annual Preface

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: First Time Generics and Drugs@FDA

U.S. Food and Drug Administration. Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: Orange Book Annual Preface