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`United Therapeutics Europe Ltd.
`Unither' House. Curfew Bell Fload
`Chertsey,8uwoyl<T159FG
`United Kingdom
`Tel: +44 [E31932 57’38CD
`Fax: +44 [(31932 ENHO
`
`17th February 2010
`
`Dr Eric Abadie, CI—IMP Chair
`European Medicines Agency
`'i' Westfei‘ry Circus
`Canary Wharf
`London
`E14 4H3
`United Kingdom
`
`RE: Withdrawal of Marketing Authorisation Application for 'l‘yvaso”
`(treprostinil sodium) 0.6 mgi’ml NcbnliSer Solution. (EMEA {BUCK 001115)
`Dear Dr Abadie,
`
`I wonid like to inform you that, at this point oftinie, United Therapeutics Europe, Ltd,
`has taken the decision to withdraw the marketing authorisation application for Tyvaso‘”
`(treprostinil sodium), 0.6 mghnl, nebuliser solution, which was intended for use as
`adjuvant therapy in patients with pulmonary arterial hypertension who were also
`receiving either an endothelin receptor antagonist or a phosphodiesterase-S inhibitor.
`
`The withdrawal is based on the following:
`
`A major objection noted that findings ofiioincoinplianee with good clinical practice
`(GCP) at two clinical sites would preclude a recommendation for approval. There were
`no major objections at the time of withdrawal on the safety or efficacy of 'l‘yvaso.
`
`At this time there is one on-going clinical study in Europe, the open-label extension
`safetyr study, and Tyvaso is also being supplied on a compassionate use basis at one
`specialist treatment centre in Germany. Treatment of these patients will continue until
`alternative treatment options are obtained.
`
`United Therapeutics Europe, Ltd. reserves the right to make further submissions at a
`future date in this or other therapeutic indication(s).
`
`1 agree for this letter to be published on the EMA website.
`
`Yours sincerely,
`
`Tyriraso‘”n EMIEA H'UCI' 00! [is
`MAA withdrawal loner
`
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`Medicines for Life-m
`
`Registered in England 3938816 at Unither House. Curlew Bell Road. Clzsrcsen Sur‘mv I<T16 QFG
`
`UNITED THERAPEUTICS, EX. 2086
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR2017-01622
`
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