- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
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 Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
