Zyban Generics Enter Market; Impax/Teva Launch After Andrx Surrenders Exclusivity
This article was originally published in The Pink Sheet Daily
Executive Summary
Andrx will share in the profits of Impax/Teva’s bupropion 150 mg for smoking cessation for six months. Relinquishment of first-to-file rights mirrors Andrx’ earlier decision to give up exclusivity on Wellbutrin SR.
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Andrx’ Florida Manufacturing Operations Subject Of Second FDA-483 Notice
FDA has provided “conflicting information” about whether GMP issues will delay ANDA approvals, Andrx says. The company is slated to meet with FDA in the next 60 days to discuss implementation of a corrective action plan that would address Form 483 observations issued in March and July.
Andrx’ Florida Manufacturing Operations Subject Of Second FDA-483 Notice
FDA has provided “conflicting information” about whether GMP issues will delay ANDA approvals, Andrx says. The company is slated to meet with FDA in the next 60 days to discuss implementation of a corrective action plan that would address Form 483 observations issued in March and July.
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