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The proposed rule for drugs and biologics reporting does not apply to safety reports filed under an investigational new drug application, annual reports that manufacturers submit to the FDA.
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Clavamox is approved for treatment of the following canine infections:
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Clavamox is a combination of Amoxicillin and Clavulanate.
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The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA