Food and Drug Administration Approvals, February 2003
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:
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
Antilipemic Agents
Antihypertensive Agents
Anti-infective Agents
Antineoplastic Agents
Cardiovascular Agents
Central Nervous System Agents
Dermatologic Agents
Estrogens
Immunosuppressive Agents
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