Breckenridge Pharmaceutical Inc, a subsidiary of Towa Pharmaceutical, announced on Thursday that it has received final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Apixaban Tablets (generic for Eliquis).
Towa Pharmaceutical Europe, SL produced the product at its Martorelles, Spain manufacturing facility. According to industry sales data, Eliquis generated annual sales of USD14 billion during the twelve months ending May 2021.
The company has received a license under confidential terms allowing Breckenridge to introduce generic Apixaban Tablets under its ANDA at a later date.
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