United Therapeutics refiles Remodulin NDA
This article was originally published in Pharmaceutical Approvals Monthly
FDA Cardiovascular and Renal Drugs Advisory Committee recommends approval of United Therapeutics' pulmonary hypertension therapy Remodulin Aug. 9. The company refiled the Remodulin NDA, which was withdrawn by the firm in advance of the July 16 user fee date, on the same day. Though FDA has six months to review the submission, the firm expects a decision more quickly
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