-----Original Message-----
From: U.S. Food & Drug Administration (FDA)
Sent: 11/9/2011 2:18:58 PM
To: guyperea@live.com
Subject: CDER New: November 9, 2011
What's New on the FDA Drugs Site
November 8, 2011
- BPCA/Pediatric Exclusivity Statistics:
- Pediatric Exclusivity Statistics (updated)
- Written Requests Issued (updated)
- CDER Ombudsman: Dispute Resolution
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
- Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad de medicamentos usados para el tratamiento del Trastorno de Déficit de Atención con Hiperactividad (ADHD por sus siglas en inglés) en niños y adultos jóvenes
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 377KB)
- Drug Shortages: Current Drug Shortages: Tetracycline Capsules
- Electronic Common Technical Document (eCTD) (updated)
- FDA launches new website on safe disposal of used needles and other "sharps"
November 7, 2011
- The Adverse Event Reporting System (AERS): Latest Quarterly Data Files (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 376KB)
- Drug Shortages: Current Drug Shortages: Labetalol Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
- Drug Shortages: Current Drug Shortages: Vecuronium Injection (updated)
- FDA approves Erbitux (cetuximab) to treat late-stage head and neck cancer
- National Drug Code Directory Data File Download (updated)
New and Generic Drug Approvals
November 8, 2011
- Levocetirizine Dihydrochloride Oral Solution, Synthon Pharmaceuticals, Inc., Approval
November 7, 2011
- Erbitux (cetuximab) Injection, ImClone LLC, Supplement
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