MYLAN GETS OK FOR FENTANYL PATCH, TENTATIVE OK FOR GENERIC VALTREX

Mylan Laboratories announced that the FDA has granted final approval for Mylan Technologies' supplemental abbreviated new drug application for its 12 micrograms/hour fentanyl transdermal system. This product is shipping immediately.

Mylan's product was the first generic Class 2 narcotic transdermal product approved by the FDA, and Mylan is now the first generic company to offer all five strengths of generic transdermal fentanyl. It is the generic version of Alza's Duragesic patch, which is indicated for treating chronic pain.

The company also announced it has received tentative approval for its generic version of valacyclovir hydrochloride tablets, 500 and 1,000 mg.

The drug is the generic version of GlaxoSmithKline's Valtrex, which had U.S. sales of approximately $1.26 billion for the 500- and 1,000-mg strengths during the 12-month period ending in September 2006, according to IMS Health.