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January 2005

26
January 2005
The year 2004 ended with the US Food and Drug Administration (FDA) approval of new agents for macular degeneration, overactive bladder, pain management, pediatric leukemia, and mucositis. The approval of these very novel agents fills a void where there is no currently approved therapy or alternatives for some patients and diseases.

This month's column reviews FDA new product approvals and labeling changes for:

Analgesic Agents


  • Prialt (ziconotide) Intrathecal Injection


Antineoplastic Agents


  • Clolar (clofarabine) Injection


Anti-Ulcer Agents and Acid Suppressants


  • Nexium (esomeprazole) Capsules


Chemoprotectant Agents


  • Kepivance (palifermin) Injection


Genitourinary Agents


  • Enablex (darifenacin) Extended-Release Tablets


Ophthalmic Agents


  • Macugen (pegaptinib) Injection

  • Vision Blue (trypan blue) Ophthalmic Solution


Source...
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