Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to produce and sell Oxcarbazepine tablets in strengths of 150 mg, 300 mg, and 600 mg. Oxcarbazepine tablets is the generic of Trileptal Tablets, a drug commonly used to treat seizure disorders like epilepsy. This significant approval allows Zydus Lifesciences to […]
Granules India has announced its receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets USP, in 250 mg, 500 mg, 750 mg, and 1,000 mg strengths. The drug, bioequivalent and therapeutically equivalent to UCB, Inc.’s reference listed drug (RLD), Keppra Tablets, is used […]
Zydus Lifesciences (previously Cadila Healthcare) said that its subsidiary Zydus Pharmaceuticals (USA) Inc. has launched Topiramate Extended-Release Capsules in the US. The launch follows the final approval received by Zydus Pharmaceuticals (USA) from the US Food and Drug Administration (FDA) for marketing Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg. The approved […]
Lupin Limited said that it has secured approval for Vigabatrin for Oral Solution USP, 500 mg, an anti-epileptic drug, from the US Food and Drug Administration (FDA). The US pharma regulator approved the abbreviated new drug application (ANDA) of the Lupin product, which is a generic of Sabril for Oral Solution, 500 mg owned by […]
Zydus (Cadila Healthcare) has secured final approval from the US Food and Drug Administration (FDA) to market Vigabatrin Tablets in the strength of 500mg. Vigabatrin Tablets is the generic version of Sabril Tablets. It is indicated in the US for the treatment of babies, aged one month to two years, having infantile spasms. The drug […]
MGC Pharmaceuticals, a developer of phytocannabinoid-derived medicines, has signed a $24 million supply and distribution deal with US-based AMC Holdings. The deal is for the supply of the company’s products, which include epilepsy candidate CannEpil, dementia and Alzheimer’s candidate CogniCann, and CimetrA over an initial three-year period. MGC Pharmaceuticals said that this is its maiden […]
Cadila Healthcare (also known as Zydus Cadila) said that it has secured tentative approval from the US Food and Drug Administration (FDA) to market Brivaracetam Tablets in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. Brivaracetam is approved for the treatment of partial-onset of seizures (epilepsy). Zydus Cadila will […]
In a significant move within the pharmaceutical industry, Irish biopharma company Jazz Pharmaceuticals has announced an agreement to acquire British-based GW Pharmaceuticals in a monumental $7.2 billion cash-and-stock transaction. This acquisition is set to create a powerhouse in the neuroscience field with a robust global commercial and operational footprint. Strategic Acquisition to Enhance Neuroscience Portfolio […]
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 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 […]