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Ann: Launch of Dapsone 5%, Gel in the United States, page-20

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Viceman

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05/04/24

07:24

Post #: 73198621
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Originally posted by jetrodder: ↑

We currently have 3 ANDA's awaiting approval from the FDA. The first mention of Dapsone 7.5% that I have found was 23rd Nov 2022 that this ANDA was currently awaiting approval. I could not find a mention of this ANDA being before the FDA, before that date. Acyclovir Cream mentioned 8/8/22 and Nitroglycerin Ointment 4% 4/7/23. Dapsone has now spent some 16-17 months with the FDA. Hopefully within 6 months this can be launch. On the 27th of May 2022, ACR announced that it had a successful patent ligation and that ACR will be able to launch Aczone (Dapsone) Gel 7.5% once it has FDA approval. Jet

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Hey.Jetrodder. Found out that the Dapsone 7.5% gel was accepted for review by the FDA on the 15/04/21,nearly 3 years ago.

ACR Price at posting: 6.9¢ Sentiment: Buy Disclosure: Held
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