Alpharma ANDA Approvals On Hold
This article was originally published in The Pink Sheet Daily
Executive Summary
Approvals of Alpharma ANDAs for oral solid dose formulations are on hold "pending a successful follow-up inspection" by FDA of an Elizabeth, N.J. manufacturing facility, the company said May 7.
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Approvals of Alpharma ANDAs for oral solid dose formulations are on hold "pending a successful follow-up inspection" by FDA of an Elizabeth, N.J. manufacturing facility, the company said May 7. The delay in approvals does not affect Alpharma's ability to launch gabapentin capsules (Pfizer's Neurontin ); Alpharma received final ANDA approval in September with 180 days of generic marketing exclusivity. However, the firm's ANDA for gabapentin tablets is pending. Alpharma and Teva have entered into an agreement that would allow Teva to launch gabapentin during Alpharma's exclusivity period (1 (Also see "Teva, Ivax Move Closer To Marketing Generic Gabapentin; Neurontin Litigation Continues" - Pink Sheet, 28 Apr, 2004.)). Neither company has announced launch plans; patent litigation with Pfizer is ongoing. |