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FDA Approvals - US FDA Grants Pediatric Exclusivity For UCB's Keppra(R) (Medical News


US FDA Grants Pediatric Exclusivity For UCB's Keppra(R) (Medical News Today)
UCB announced that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001.

FDA Announces New Labeling Changes For Regranex (Medical News Today)
The U.S. Food and Drug Administration announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.
 

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