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July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
02 Jan 2024 18:39 GMT
… (amoxicillin and clavulanate potassium)
Moxatag (amoxicillin extended-release tablets)
… axicabtagene ciloleucel)
Post-treatment T-cell malignancy
FDA is evaluating the …
FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam …
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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
13 Sep 2023 02:34 GMT
… )
Vernalis (R&D) Limited
Moxatag (amoxicillin extended-release) tablets
3 … /30/14)
The Medicines Company
Cleviprex (clevidipine) IV emulsion … )*
Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.)
Sprix (ketorolac tromethamine) Nasal …
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Vernalis PLC: FDA Issues Complete Response Letter on CCP-08 NDA
07 Aug 2017 06:20 GMT
… Food and Drug Administration (FDA) has issued … stage pharmaceutical company with significant expertise in drug … treatment of tonsillitis and/or pharyngitis secondary to Streptococcus … Moxatag®, frovatriptan and other products by consumers and medical …
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FDA knocks-back second Vernalis cough and cold treatment
16 Aug 2017 11:59 GMT
… April the Food and Drug Administration (FDA) sent a complete … it already has a medicine on the US market … including Moxatag (amoxicillin extended release) indicated for the treatment of … and frovatriptan for the acute treatment of migraines.
Please enable …
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FDA Issues Complete Response Letter on CCP-08 NDA
07 Aug 2017 06:31 GMT
… Food and Drug Administration (FDA) has issued … stage pharmaceutical company with significant expertise in drug … treatment of tonsillitis and/or pharyngitis secondary to Streptococcus … Moxatag®, frovatriptan and other products by consumers and medical …
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Servier and Vernalis plc announce achievement of 3 milestones in their oncology drug discovery collaboration
26 Apr 2017 06:07 GMT
… treatment of the first patient in a Servier sponsored trial … pharmaceutical company with significant expertise in drug … treatment of tonsillitis and/or pharyngitis secondary to Streptococcus … Moxatag®, frovatriptan and other products by consumers and medical …
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Vernalis PLC: FDA Issues a Complete Response Letter on CCP-07 NDA
21 Apr 2017 06:22 GMT
… Food and Drug Administration (FDA) has issued … stage pharmaceutical company with significant expertise in drug … treatment of tonsillitis and/or pharyngitis secondary to Streptococcus … Moxatag®, frovatriptan and other products by consumers and medical …
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Vernalis achieves a $3 million milestone payment from Corvus Pharmaceuticals Inc
14 Feb 2017 07:23 GMT
… a US-based biotechnology company focused on … stage pharmaceutical company with significant expertise in drug … treatment of tonsillitis and/or pharyngitis secondary to Streptococcus … Moxatag®, frovatriptan and other products by consumers and medical …
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achieves a $3 million milestone payment from Corvus Pharmaceuticals Inc
14 Feb 2017 07:05 GMT
… a US-based biotechnology company focused on … stage pharmaceutical company with significant expertise in drug … treatment of tonsillitis and/or pharyngitis secondary to Streptococcus … Moxatag®, frovatriptan and other products by consumers and medical …
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Vernalis PLC: FDA accepts CCP-08 NDA for full review
21 Dec 2016 07:03 GMT
… have to swallow a pill. Tris' … stage pharmaceutical company with significant expertise in drug development … treatment of tonsillitis and/or pharyngitis secondary to Streptococcus … Moxatag®, frovatriptan and other products by consumers and medical …