Forest and its licensing partner Mylan submitted a response to an FDA "approvable" letter for nebivolol, a selective beta-1 blocker in development for hypertension, Forest announced May 1. The company said it expects FDA could complete its review of the application within six months following acceptance.

"We believe the supplemental data will provide the FDA with the information they have requested," Forest said. The company has called the additional data pharmacological in nature, small and of short duration.

Forest told "The Pink Sheet" DAILY it is ramping up prelaunch activities in anticipation of an early 2008 launch of nebivolol for hypertension.

The firm licensed nebivolol from Mylan in January 2006, assuming all sales and marketing responsibility for the drug. The approvable letter, issued in 2005, requests submission of additional preclinical data (¹ Also see "Mylan Finds Its Way Out Of The Woods: Forest Signs Nebivolol Licensing Agreement" - Pink Sheet, 12 January, 2006.).

Forest is also pursuing a congestive heart failure indication for nebivolol. However, the company said in January it intends to await the review for hypertension before submitting the CHF application (² Also see "Forest Will Delay Nebivolol NDA For CHF Pending FDA Review Of Hypertension Data" - Pink Sheet, 16 January, 2007.).

Nebivolol is approved and marketed for hypertension in 50 countries.

-Jessica Merrill (j.merrill@elsevier.com)

Forest/Mylan Respond To FDA “Approvable” Letter On Nebivolol

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