• 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, January 2009 (Banzel, tapentadol, synthetic conjugated estrogens-A, Ranexa)

Article

Recent FDA approvals (through January 2009) related to Banzel, tapentadol, synthetic conjugated estrogens-A, and Ranexa

Rufinamide (Banzel, Eisai) was approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children aged ≥4 years and adults.

Tapentadol immediate-release tablets (Johnson & Johnson) were approved for the relief of moderate-to-severe acute pain in adults aged ≥18 years.
Synthetic conjugated estrogens-A (SCE-A) 0.625 mg/g vaginal cream (Duramed) was approved for the treatment of moderate-to-severe vaginal dryness and pain with intercourse.

Ranolazine (Ranexa, CV Therapeutics) was approved for the first-line treatment of chronic angina.

Related Content
© 2024 MJH Life Sciences

All rights reserved.