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Apotex minutes late on potassium CGT

 
• By Aidan Fry

Apotex missed by a matter of minutes its opportunity to block competition to the Canadian company’s potassium chloride 10% oral solution in the US, the US Food and Drug Administration (FDA) has determined. Therefore, the agency denied Apotex’ request to rescind approval for Novel Laboratories’ abbreviated new drug application (ANDA) for an alternative to Genus Lifesciences’ reference drug.

Apotex missed by a matter of minutes its opportunity to block competition to the Canadian company’s potassium chloride 10% oral solution in the US, the US Food and Drug Administration (FDA) has determined. Therefore, the agency denied Apotex’ request to rescind approval for Novel Laboratories’ abbreviated new drug application (ANDA) for an alternative to Genus Lifesciences’ reference drug.

When Apotex submitted its ANDA for potassium chloride 10% and 20% to the FDA for review in October 2017, the company requested that the drugs be designated as competitive generic...

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