New FDA Approvals
New FDA Approvals
These drugs have received final approval from the U.S. Food and Drug Administration:
- Antineoplastic drug Viadur (leuprolide acetate implant) by ALZA Corp. Viadur is indicated for palliative treatment of advanced prostate cancer. Each implant contains 72 mg leuprolide acetate (equivalent to 65 mg leuprolide free base) and is inserted subcutaneously in the inner aspect of the upper arm to deliver a continuous dose of leuprolide. Implant must be removed after 12 months of therapy, at which time another implant may be inserted.
- Antiepileptic agent Zonegran (zonisamide) by Dainippon Pharmaceutical USA Corp. Zonegran is indicated as adjunctive therapy in treatment of partial seizures in adults with epilepsy. Chemically classified as a sulfonamide and is unrelated to other antiepileptic drugs. Supplied as 100 mg capsule for oral administration to be given once or twice daily.
- Apnea agent Cafcit (caffeine citrate) Injection by Boehringer Ingelheim Pharmaceuticals Inc. Cafcit has received FDA approval for short-term treatment of apnea of prematurity (AOP) in infants between 28 and 33 weeks gestational age. Cafcit received Orphan Drug Status and is the only product approved for treatment of AOP. Available in ready-to-use 3 mL single-dose vials containing caffeine citrate at a concentration of 20 mg/mL (60 mg/vial), equivalent to 10 mg/mL caffeine base. Cafcit is dosed once daily.
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