Roxane Laboratories, Inc. announces the launch of buprenorphine 1/2 HCl sublingual tablets Columbus, OH – October 8, 2009.
Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl Sublingual Tablets,
2mg and 8mg by the U.S. Food and Drug Administration. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories’ Buprenorphine HCl Sublingual Tablets are AB rated to SUBUTEX® (buprenorphine HCl) tablets. Annual sales of SUBUTEX® are approximately $67.7 Million.
Full prescribing information for Buprenorphine HCl Sublingual Tablets is available on the Roxane Laboratories website at www.Roxane.com or upon request by calling Roxane Laboratories
Technical Product Information at 1.800.962.8364.