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Home » Apotex Hits Timing Snag Over 180-Day Exclusivity for Competitive Generic Therapy
Apotex Hits Timing Snag Over 180-Day Exclusivity for Competitive Generic Therapy
The FDA denied a request by Canadian drugmaker Apotex to rescind its approval of a competing ANDA for a potassium chloride oral solution submitted by Novel Laboratories — granted on the same day Apotex qualified for 180-day competitive generic therapy (CGT) exclusivity.