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Martec nifedipine XL

Executive Summary

"To the best of our knowledge...Mylan has only filed and obtained tentative approval for the 30 mg" strength of nifedipine extended-release, a generic form of Pfizer's Procardia XL, Martec Scientific states in a letter to "The Pink Sheet." Mylan received tentative approval for 30 mg nifedipine XL March 15. Martec noted it has filed for 30 mg, 60 mg and 90 mg tablets, and pointed out the "exclusivity status is not fully clear" for the different strengths ("The Pink Sheet" April 5, p. 10)

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