Orphan Medical's Cystadane for homocystinuria is firm's second approval within month.

ORPHAN MEDICAL CYSTADANE IS SECOND APPROVAL IN ONE MONTH for the Minnetonka, Minn.-based pharmaceutical company. Betaine anhydrous oral solution was approved Oct. 20 for "the treatment of homocystinuria to decrease elevated homocysteine blood levels" ("The Pink Sheet" Oct. 28, In Brief). Cystadane is the first drug to receive FDA approval for the treatment of homocystinuria, a rare genetic disorder caused by various inborn errors of methionine metabolism that affects about 1,000 patients in the U.S. The drug was classified a "1PV" by FDA, denoting a new molecular entity with orphan status given a priority review.