CDER New May 15, 2013

May 14, 2013

• FDA Press Release: FDA approves Nymalize—first nimpdipine oral solution for use in certin brain hemorrhage patients
• FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use
• Guidance for Industry: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data (PDF - 501KB)