October 2002
October 2002
The US Food and Drug Administration (FDA) approved 2 original drug applications in September 2002. The first is Hepsera (adefovir dipivoxil) for the treatment of chronic hepatitis B. The second is Inspra (eplerenone) for the treatment of hypertension.
Antihypertensives Avapro (irbesartan) and Cozaar (losartan) gained approval for a new indication for use in patients with type 2 diabetes for the treatment of nephropathy.
This month's column reviews FDA new product approvals and labeling changes for these products as well as the following:
Antifungal Agents
Antihypertensive Agents
Anti-Infective Agents
Antilipemic Agents
Antiviral Agents
Dermatologic Agents
Gastrointestinal Agents
Nonsteroidal Antiestrogens
Vaccines
The US Food and Drug Administration (FDA) approved 2 original drug applications in September 2002. The first is Hepsera (adefovir dipivoxil) for the treatment of chronic hepatitis B. The second is Inspra (eplerenone) for the treatment of hypertension.
Antihypertensives Avapro (irbesartan) and Cozaar (losartan) gained approval for a new indication for use in patients with type 2 diabetes for the treatment of nephropathy.
This month's column reviews FDA new product approvals and labeling changes for these products as well as the following:
Antifungal Agents
Cancidas (caspofungin)
Antihypertensive Agents
Atacand (candesartan cilexetil)
Avapro (irbesartan)
Cozaar (losartan)
Inspra (eplerone)
Anti-Infective Agents
Augmentin XR extended-release tablets
Antilipemic Agents
Mevacor (lovastatin)
Antiviral Agents
Hepsera (adefovir dipivoxil)
Valtrex (valacyclovir)
Dermatologic Agents
Aldara
Gastrointestinal Agents
Prevacid SoluTab (lansoprazole)
Nonsteroidal Antiestrogens
Nolvadex (tamoxifen)
Vaccines
Fluzone (preservative-free influenza virus vaccine) intramuscular injection
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