Andrx complaint seeking generic exclusivity for diltiazem extended-release challenges FDA policy.
ANDRX COMPLAINT CHALLENGES FDA GENERIC EXCLUSIVITY POLICY that 180-day exclusivity will go to the first company successfully defending paragraph IV certification for a generic product, and that subsequent applications for the same product may be approved while the patent suit is pending. FDA published the policy in the Nov. 28 Federal Register ("The Pink Sheet" Dec. 1, 1997, T&G-15).
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