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news.US-based pharmaceutical firm Mylan has entered into a settlement and license agreement with Pfizer relating to its Abbreviated New Drug Application (ANDA) filed with the US Food and Drug Administration (FDA) for Celecoxib Capsules, 50mg, 100mg, 200mg and 400mg.
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The drug is the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and for the management of acute pain in adults.
As part of the agreement, Mylan will start selling the drug at the earliest market formation, however in any case not later than December 2014.
All other terms and conditions of the settlement and license deal are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.
In addition, Mylan has appealed the decision by the US District Court for the Northern District of West Virginia denying the company’s request for an injunction in its suit against the FDA.
The company continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the aforementioned settlement.