The 505(b)(2) process is used to obtain approval of an isomer of an already approved racemate. An example is cetirizine. The original product approved (Zyrtec) is a racemate. In May 2007, UCB, Inc. obtained approval for levocetirizine dihydrochloride 5 mg tablets, using the 505(b)(2) process. That approval was based on replicate clinical studies. On 1/28/2008 UCB obtained [...]
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You are currently browsing the Drug Kennel weblog archives for the day Sunday, May 4th, 2008.
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