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January - March 2019 | Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
16 Sep 2024 17:01 GMT
… (amoxicillin and clavulanate potassium)
Moxatag (amoxicillin)
Omeclamox-Pak (omeprazole … -acting antiviral drugs for the treatment of chronic … labeling, and the “Medication Guide” were updated in …
Zepatier labeling
An FDA Drug Safety Communication for Mavyret …
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These Are the Drugs America Is Running Short On
29 Apr 2024 17:19 GMT
… image of too many pills.
Brand Name: Amoxicot, Amoxil, Moxatag
Category: Antibiotic
Uses: The drug is used to … is a common treatment for asthma attacks.
Shortage Started: February, 2024
Reason for shortage: Akorn Pharmaceuticals declared Chapter 7 …
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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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Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2007-2012
18 Sep 2024 16:26 GMT
Drug
Sponsor
Medical Review
Clinical Pharmacology Review
…
Amoxicillin/APC -111 - Moxatag
MiddleBrook Pharmaceuticals
Medical (PDF -3MB)
Clinical pharmacology ( … System - Daytrana
Shire Pharmaceuticals
Medical (PDF -2MB)
Medical (PDF -36KB)
Clinical …
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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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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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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 …
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