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BRIEF-Lipocine ‍resubmits NDA for oral testosterone product candidate
2017年8月9日 / 下午12点44分 / 3 个月前

BRIEF-Lipocine ‍resubmits NDA for oral testosterone product candidate

Aug 9 (Reuters) - Lipocine Inc:

* Says ‍resubmits NDA for its oral testosterone product candidate, LPCN 1021, for treatment of hypogonadism​

* Lipocine says it had received a complete response letter from U.S. FDA in June 2016 that identified a deficiency related to dosing algorithm for proposed label

* Lipocine - to address deficiency, co completed dosing validation study that confirmed validity of fixed dose approach without need for dose titration to orally administer LPCN 1021​

* Lipocine inc - ‍anticipates six-month review by FDA with projected PDUFA date in Q1 of 2018 assuming fda acknowledges co’s submission Source text for Eikon: Further company coverage:

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