February 2003

Introduction

The US Food and Drug Administration (FDA) announced on January 31, 2003, a new initiative titled "Improving Innovation in Medical Technology: Beyond 2002." The FDA is proposing to establish new regulatory standards and processes to bring to market quicker and less costly new and emerging drugs, biologics, devices, and veterinary medicines. The proposal includes:

• Reducing the delays and excess product development costs by avoiding multiple cycles of FDA review when possible, through early communication and other steps to improve the quality of new product applications.
  
  

• Improving the quality and efficiency of the review process, by adopting a quality systems approach to medical product reviews.
  
  

• Facilitating new product development, by providing clearer up-to-date guidance for particular diseases and for emerging technologies.
  
  

To highlight the need for a change in the regulatory processes, the FDA illustrated that the number of total products approved in 2002 had increased at the same time that there were fewer marketing applications and longer total approval times in some significant product areas.

The decrease in new molecular entities is demonstrated in this month's FDA Approvals column, where there are several significant supplemental approvals but only 1 New Drug Application (NDA) and 1 new Biologics License Application (BLA). The NDA for Xanax XR was approved by the FDA for the treatment of panic disorder. The BLA for Amevive (alefacept) injection was approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Amevive is an immunosuppressive dimeric fusion protein.

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

Antidepressants

• Prozac (fluoxetine HCl) capsules
  
  

Antilipemic Agents

• Lopid (gemfibrozil) tablets
  
  

Antihypertensive Agents

• Atacand (candesartan cilexetil) tablets
  
  

• Diovan HCT (valsartan/hydrochlorothiazide) tablets
  
  

Anti-infective Agents

• Cancidas (caspofungin acetate) injection
  
  

• Zyvox (linezolid) tablets and injection
  
  

Antineoplastic Agents

• Busulfex (busulfan) injection
  
  

Cardiovascular Agents

• Imdur (isosorbide mononitrate) extended-release tablets
  
  

• Tenormin (atenolol) tablets
  
  

Central Nervous System Agents

• Xanax XR (alprazolam) extended-release tablets
  
  

Dermatologic Agents

• Amevive (alefacept) injection
  
  

Estrogens

• Premarin (conjugated estrogens) tablets
  
  

• Prempro (conjugated estrogens/medroxyprogesterone acetate) tablets
  
  

Immunosuppressive Agents

• Rapamune (sirolimus) oral solution & tablets
  
  

Medscape Pharmacists. 2003;4(1) © 2003 Medscape

Cite this: February 2003 - Medscape - Feb 20, 2003.