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The data management unit in China is tailored for local Chinese registration trials and the data management unit in the Philippines will focus on high-volume, cost-effective data entry projects for Phase IV trials required by the Philippines Bureau of Food and Drugs (BFAD) regulatory authorities.
In addition to having received 180-day exclusivity from the Federal Bureau of Food and Drug Administration (FDA) for the gabapentin 100, 300 and 400 mg tablets, IVAX has received tentative approval from the FDA for the gabapentin 100, 300 and 400 mg capsules.