Teva Sues US FDA To Obtain 180-Day Exclusivity For Its Generic Restasis

Complaint challenges agency's revised definition of "first applicant," which does not require notice of Paragraph IV certification to obtain exclusivity.

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Teva Pharmaceuticals USA Inc.'s suit against the US FDA aims to obtain 180-day exclusivity for its generic version of Allergan PLC's Restasis (cyclosporine) and to eliminate the agency's new policy redefining "first applicant."

Teva's complaint is in response to a letter FDA issued in July to applicants of abbreviated new drug applications for generic versions of Indivior PLC's Suboxone (buprenorphine/naloxone) sublingual film. In the letter, the agency set forth a new definition of "first applicant," whereby a sponsor does not lose this status by failing to provide timely notice of Paragraph IV certification to the brand manufacturer

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