02
Mar

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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25
Feb

Damned If You Do and Damned If You Don’t – Thinking About a New Permanent Commissioner

There appears to be some concern about Janet Woodcock, MD being selected for the permanent FDA Commissioner job.  Not sure why there is so much hype and concern.  Most of the pressure being applied from the non-supporters focus on the opioid crisis; however, some critics are being quick to complain about the approval actions that […]

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12
Feb

Skinny Label Reprieve, But Not Out of the Woods Yet!

The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label.  Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case.  Clearly, Congressional intent and regulatory […]

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09
Feb
Complexity Image

Complex Generics and the Prescription Landscape – The Hill Webinar

Today, The Hill hosted a webinar called “Complex Generics & the Prescription Drug Landscape.”  Many thanks to The Hill for their efforts.  The takeaway messages from the program participants are important, especially as the current Generic Drug User Fee Amendments III (GDUFA III) negotiations are revving up for the Office of Generic Drugs’ review and […]

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02
Feb

No New FDA FR Notices Since the Inauguration!

We know that a regulation hold has been placed by the Biden Administration until they can review their positions on proposed regulations, but it is highly unusual that no FR notices have appeared since Inauguration Day, January 20, 2021.  Many FR notices address issues other than regulations, including meeting notices, guidance announcements, collections of information […]

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