Shire Receives Approvable Letter For Carbatrol; Lambda To Enter Ph II

- Shire Pharmaceuticals has received an approvable letter from the USFood and Drug Administration for Carbatrol (carbamazepine sustained-release), for the treatment of epilepsy and as a specific analgesic for trigeminal neuralgia. Certain manufacturing and control items need to be finalized with regard to the drug, as does product labeling, before the agency will approve Carbatrol, says the company. In a separate statement, following the successful completion in Phase I trials with Lambda, Shire is to push the drug through to Phase II, with trials to begin in July. Lambda is used to regulate blood phosphate levels in patients with kidney disease.