First generic Trileptal products get FDA nod
First oxcarbazepine receives approval for seizure disorders
Roxane Laboratories, Glenmark Pharmaceuticals, and Sun Pharmaceuticals have all received FDA approval for their generic versions of Trileptal (oxcarbazepine). The drug is indicated for use alone or in combination with other medications for the treatment of partial seizures in adults and children four years of age and older. Oxcarbazepine will be available in three strengths: 150 mg-, 300-mg, and 600-mg tablets.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
