Glaxo petitions FDA to hold generic approvals during GATT extensions; generic investment is not issue.
GLAXO PETITIONS FDA TO DELAY GENERIC ZANTAC (FORM 1) APPROVALS until after expiration of the new 20-year patent term for the anti-ulcer agent in July 1997, regardless of any substantial investment made by a generic firm into an ANDA prior to June 8, 1995. A March 7 citizen petition filed on behalf of Glaxo by the D.C. law firm of Arnold & Porter asserts that legislation implementing the General Agreement on Tariffs & Trade does not allow for marketing of generic drugs prior to the new patent expiration date because no language in the Uruguay Rounds Agreement Act specifically amends the Food, Drug & Cosmetic Act to allow such action.
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