Perrigo gets tentative FDA nod for colon cleanser

Branded HalfLytely has annual US sales of $80 million.

Perrigo Company (Nasdaq:PRGO; TASE:PRGO) has acquired the rights to Novel Laboratories Inc's generic version of HalfLytely and Bisacodyl delayed action tablets bowel prep kit for which the US Food and Drug Administration (FDA) has given tentative approval. The solution is used to prepare the bowel for colonoscopy and other procedures.

Brand HalfLytely, made by Braintree Laboratories Inc. has annual US sales of $80 million, according to Wolters Kluwer.

Novel Laboratories will manufacture the product exclusively for Perrigo, which expects to launch the kit containing the tablet and powder when the patents expire on September 25. Since Novel Laboratories was the first company to apply for an Abbreviated New Drug Application (ANDA) with the FDA, Perrigo will have 180 days marketing exclusivity.

Perrigo's share closed at $57.49 on Nasdaq yesterday, and was unchanged in early trading on the TASE today at NIS 219.60.

Published by Globes [online], Israel business news - - on June 3, 2010

© Copyright of Globes Publisher Itonut (1983) Ltd. 2010

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