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 Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More
