Monday, November 01, 2021 7:01:47 AM
Still not sure about the updated labeling last Friday. Per the announcement:
Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.
Presume the trade label got updated based on the generic labeling and its subsequent approval under this most recent fda application.
Excited to hear what will be discussed during earnings.
-RG
Recent ANIP News
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- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/18/2024 08:37:33 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 11:59:24 AM
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- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/04/2024 08:35:27 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/24/2024 12:03:53 AM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2024 11:58:03 PM
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- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/20/2024 08:57:32 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:05:00 PM
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