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Zogenix bags Fintepla FDA approval for Dravet syndrome treatment

Zogenix bags Fintepla FDA approval for Dravet syndrome treatment

Fintepla FDA approval : Zogenix has bagged approval from the US Food and Drug Administration (FDA) for Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients aged two years of age and older. Considered to be a life-threatening, rare and chronic type of epilepsy, Dravet syndrome is usually […]

Taro recalls lot of Lamotrigine tablets in US due to contamination

Taro Pharmaceuticals U.S.A. has issued to recall of a lot of Lamotrigine 100 mg tablets owing to cross-contamination with a trace of another drug substance – Enalapril Maleate. Lamotrigine is indicated for the treatment of epilepsy and bipolar disorders. The US pharmaceutical manufacturer is recalling Lot # 331771, which has an expiration date June 2021 […]

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SK Biopharmaceuticals bags XCOPRI FDA approval for partial-onset seizures

XCOPRI FDA approval : SK Biopharmaceuticals said that its US subsidiary SK Life Science has been granted approval from the US Food and Drug Administration (FDA) for its anti-epileptic drug XCOPRI (cenobamate tablets) for the treatment for partial-onset seizures in adults. According to the FDA, a seizure is normally a short episode of abnormal electrical activity […]

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Stokes’ STK-001 secures FDA orphan drug designation for Dravet Syndrome

US biotech company Stoke Therapeutics has secured orphan drug designation for its lead product candidate – STK-001 from the US Food and Drug Administration (FDA) for the treatment for Dravet syndrome. Considered to be a severe and progressive genetic epilepsy, Dravet syndrome is characterized by frequent, prolonged and refractory seizures that start within the first […]

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AgeneBio enrolls first patient in AGB101 phase 3 trial in MCI due to AD

AgeneBio, a US-based CNS biopharma company, enrolled the first patient in a phase 3 clinical trial to study the efficacy of AGB101 for the treatment of amnestic Mild Cognitive Impairment caused by Alzheimer’s Disease (MCI due to AD). The late-stage trial, known as HOPE4MCI, will enroll a total of 830 patients, aged between 55 and […]

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Martindale Pharma's clobazam oral suspension for Epilepsy approved

UK based Martindale Pharma has secured a regulatory approval of its clobazam oral suspension medicine in seven European countries. Branded as Epaclob, the global pharma company’s clobazam oral suspension has been approved in France, Iraland, Germany and Italy. In Denmark, Spain and Iceland, the same clobazam oral suspension which is branded as Silocalm, has also […]

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