Celexa Generic Approvals Reflect Timely Responses To ANDA Deficiencies
This article was originally published in The Pink Sheet Daily
Executive Summary
When multiple ANDAs are filed at the time a product’s new chemical entity exclusivity expires, “it becomes a horserace to approval,” OGD Director Buehler observes. FDA approved five citalopram ANDAs slightly more than nine months after Celexa’s exclusivity expired.
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