New life for thalidomide
Category:
Miscellany
The Pharma Industry
Submitted by pharmamanufacturing
on Thu, 05/25/2006 - 22:43

FDA just released the following news. Celgene's formulation of thalidomide has just been approved by FDA for use (with dexamethasone) in treating multiple myeloma. Thalidomide, the most infamous of teratogens, has long been the textbook example of a chiral drug with "good" and "bad" enantiomers. Here's the official word from FDA:
Today, May 25, 2006, the Division of Drug Oncology Products in conjunction with the Division of Special Pathogen and Transplant Products approved the following application:
NDA: sNDA 21-430 (Type 6) and NDA 20-785/S-031
Drug: Thalomid (thalidomide) 50 mg, 100 mg and 200 mg capsules
Applicant: Celgene Corporation
Indications: Thalomid (thalidomide) 50 mg, 100 mg and 200 mg capsules in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma.
Route of administration: Oral
-AMS