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FDA approved the first generic version of oseltamivir phosphate (Tamiflu, Roche) for oral suspension to treat influenza A and B, plus 2 other noteworthy therapies.
FDA approved the first generic version of oseltamivir phosphate (Tamiflu, Roche) for oral suspension to treat influenza A and B, along with a new indication for an antiepileptic drug and the first oral antibiotic for bacterial vaginosis.
While the agency approved the first generic version of Tamiflu last year, the new generic Tamiflu from Nesher Pharmaceuticals is for patients who are not able to ingest capsules, according to FDA.
The new oral suspension is indicated for patients aged 2 weeks and older who have had flu symptoms for no more than 48 hours, as well as to prevent flu in patients one year and older.
Two other noteworthy FDA approvals include:
* Brivaracetam (Briviact, UCB) received a supplemental new drug application from FDA as to treat partial-onset (focal) seizures (POS) in patients aged 16 years and older with epilepsy.
This is a new indication for Briviact, which is already approved in the United States as adjunctive treatment for POS in patients in this age group. “As a result, adults and adolescents aged 16 years and older with POS in the US can now be initiated on Briviact as monotherapy or adjunctive therapy,” UCB said in a statement.
Briviact is the newest antiepileptic drug in the 'racetam' class of medicines and demonstrates a high and s
elective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects, according to UCB. Gradual dose escalation is not required when initiating treatment with Briviact for monotherapy or adjunctive therapy, allowing clinicians to initiate treatment at a therapeutic dose from day one.
• Secnidazole (Solosec, Symbiomix Therapeutics) 2 g oral granules to treat bacterial vaginosis (BV) in adult women. The new drug is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the US, according to a statement from Symbiomix.
Solosec, which has been shown to be efficacious and well-tolerated, is a 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose.
“Solosec is the first new oral antibiotic to treat BV in more than a decade and will provide women with a new treatment option. We look forward to making this treatment available to patients in the first quarter of 2018.” said David L. Stern, CEO of Symbiomix.
The FDA approval was supported by a comprehensive set of studies, including 2 pivotal trials in BV and an open-label safety study, which found efficacy for single-dose secnidazole 2 g. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported, and no patients discontinued treatment due to adverse events, according to Symbiomix.