Implications of FDA's Seldane decision

WASHINGTON - The FDA's announcement last week of its intention to withdraw the approval of Hoechst Marion Roussel's Seldane (terfenadine) and Seldane D (terfenadine and pseudoephedrine), and a generic version of the antihistamine manufactured by Ivax Corp., in favor of HMR's Allegra (fexofenadine) has raised questions about what the agency will do in the future when other safer versions of approved drugs are approved.

The FDA action also may intensify the jockeying between Sepracor Inc. and HMR, which licensed U.S. rights to fexofenadine from SEPR, over worldwide marketing of the product. SEPR, which owns the use patent

Read the full 960 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE