- 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
FDA approved ranolazine extended-release tablets (Ranexa, CV Therapeutics) on January 31, 2006, for the treatment of chronic angina. A more thorough review of the agent will appear in the FDA Drug Approvals section of Formulary's March issue.
FDA approved ranolazine extended-release tablets (Ranexa, CV Therapeutics) on January 31, 2006, for the treatment of chronic angina. A more thorough review of the agent will appear in the FDA Drug Approvals section of Formulary's March issue.
An expanded indication was approved for bromfenac ophthalmic solution (Xibrom, Ista) to include the treatment of pain following cataract surgery.
Aprepitant (Emend, Merck) was approved to be used in combination with other antiemetic drugs to prevent nausea and vomiting associated with moderately emetogenic chemotherapy treatment.
The estradiol/levonorgestrel transdermal patch (Climara Pro, Berlex) was approved for the prevention of postmenopausal osteoporosis.
FDA approved lenalidomide (Revlimid, Celgene) for the treatment of patients with transfusion-dependent anemia resulting from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
FDA Approves Pfizer’s Gene Therapy for Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
