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BRIEF-Cytrx says FDA agreement on regulatory pathway for Aldoxorubicin
April 19, 2017 / 11:16 AM / 8 months ago

BRIEF-Cytrx says FDA agreement on regulatory pathway for Aldoxorubicin

April 19 (Reuters) - Cytrx Corp:

* Cytrx announces FDA agreement on regulatory pathway to approval for Aldoxorubicin in soft tissue sarcomas

* Development program can support approval, no new studies requested

* Cytrx is under confidentiality agreements with a number of companies for a commercial partnership for marketing of Aldoxorubicin

* NDA submission by Cytrx being prepared

* Goal is to submit a rolling NDA to FDA for soft tissue sarcomas in last quarter of 2017

* Proposed product label would include treatment of soft tissue sarcomas

* Is under confidentiality agreements with a number of companies for a commercial partnership for marketing of Aldoxorubicin

* Also plans to discuss with European Medicines Agency a path to filing a marketing authorization application

* Commercial launch of Aldoxorubicin is still projected for 2018 in United States Source text for Eikon: Further company coverage:

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