FDA Nixes Innovator Industry-Backed Changes To Citizen Petition Rule
Agency rejects PhRMA requests to ease certification process and limit rule's application; separately, law firm Hyman, Phelps & McNamara objects to FDA practice of delaying ANDA approval announcements until it issues a petition decision.
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Crestor Generics To Launch After 12-Day Delay
AstraZeneca's legal gambit results in almost two more weeks of sales for the statin even though the court ultimately agreed with FDA on labeling carve-out for orphan indication.
AstraZeneca Sues FDA On Crestor Generics: Fighting A 'Foregone Conclusion'?
Company is waging the same legal battle Otsuka lost last year, arguing pediatric orphan indication should block approvals of ANDAs.
180-Day Exclusivity Ruling On Cosopt Signals Need For Strong Patent Challenges
FDA's decision that Hi-Tech forfeited its generic exclusivity for Merck's ophthalmic Cosopt (dorzolamide/timolol) means that firms may need to give more weight to the strength of their patent challenges as they make filing decisions in the future