FDA actions in brief
Pregabalin (Lyrica, Pfizer) was granted an expanded indication to include the adjunctive treatment of partial onset seizures in adults with epilepsy.
Pregabalin (Lyrica, Pfizer) was granted an expanded indication to include the adjunctive treatment of partial onset seizures in adults with epilepsy.
Sildenafil (Revatio, Pfizer) was approved for the treatment of pulmonary arterial hypertension (PAH).
FDA approved meropenem 500 mg IV (Merrem IV, AstraZeneca) for the treatment of complicated skin and skin structure infections (cSSSIs).
Azithromycin extended release (Zmax, Pfizer) was approved for single-dose treatment of mild-to-moderate acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) in adults.
Tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel, sanofi pasteur) was approved for protection against tetanus, diphtheria, and pertussis in patients aged 11 to 64 years.
FDA approved insulin detemir (rDNA origin) injection (Levemir, Novo Nordisk) for the treatment of diabetes. The long-acting basal human insulin analogue has a relatively flat action profile and prolonged duration of action of up to 24 hours.
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23rd 2025An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
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