FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics

Regulatory NewsRegulatory News | 04 January 2018 |  By 

The US Food and Drug Administration (FDA) on Wednesday denied Allergan's third citizen petition attempting to block the agency from approving generic versions of the company's blockbuster Restasis (cyclosporine ophthalmic emulsion).

"This is Allergan's third petition concerning the methods an ANDA [abbreviated new drug application] applicant might use to demonstrate that a proposed generic drug is bioequivalent to Restasis. As in its previous petitions and comments to the Draft Cyclosporine BE Guidance, Allergan explains that it is opposed to the in vitro testing approach" discussed in the draft, FDA said in its denial letter.

The citizen petition denial comes as Allergan this week announced plans to cut more than 1,000 jobs as the company anticipates a generic version of Restasis to launch early this year.

Generic drugmaker Mylan, which says it's working with FDA to develop a generic version of Restasis, noted in a call for the petition to be denied: "Allergan' s latest CP is part of a serial Citizen Petition campaign, which began in 2014, to prevent generic competition to its blockbuster drug Restasis, for which Allergan has already enjoyed 15 years of exclusivity and collects revenues of nearly $1.8 billion annually."

In October, the US District Court for the Eastern District of Texas ruled that patents covering Restasis were invalid and concerns were raised over Allergan's decision to try to sell Restasis patents to a Native American tribe to block generics.

Although the attempt to block generics via a sale of patents to the tribe was novel, attempting to use the citizen petition process to block generics is not. FDA in 2016 reiterated concerns that many petitions do not raise valid scientific issues and usually only attempt to delay the approval of competitors. 


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