Refuse to Approve


After Two FDRR, FDA Set to Issue Refusal to Approve NDA for Sotagliflozin Oral Tablets

In a prepublication of a Federal Register notice (here) that will publish on March 3, 2021, the FDA has announced its intention to refuse to approve the 505(b)(1) NDA originally filed by Sanofi and now held by Lexicon Pharmaceuticals for Sotagliflozin Oral Tablets, 200 mg and 400 mg.  The product was intended to be indicated […]

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