Generics

17
Sep
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September 2021 ANDA Approval Actions Slow Through the First Half of the Month

Through the last posting on the daily approval list on September 16, OGD has reported only 16 full approval actions and one tentative approval action.  If this rate keeps up through the rest of the month, we are likely to see the fewest number of monthly approval actions since the beginning of the GDUFA program. […]

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08
Sep
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Q&A Guidance on Development of Generic Drugs During the COVID 19 Emergency

Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here).  This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants.  Remember that the answers […]

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27
Aug
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What It Is May Not Be What It Is!

In a Federal Register notice (here) that will publish on Monday, August 30th, the FDA announced that it “is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc.”  Breckenridge waived its opportunity for hearing on the proposed withdrawal. What makes this instance so […]

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20
Aug

Big Day for FDA and OGD Bioequivalence Information

Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here).  This 42‑page guidance supersedes the December 2013 draft guidance of the same name.  The document provides updated recommendations and the FDA’s current thinking on the general concepts for […]

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06
Aug

Skinny Label Is Still Losing Weight – Can It Survive or Will It Starve to Death?

In previous posts here and here, we outlined the attack on the carveout provisions of the Hatch-Waxman Act (also lovingly known as the “skinny label”) that the crafters of the Act included to ensure that generic drugs could get to consumers if there were certain patents or exclusivity issues that would otherwise block entry into […]

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