WASHINGTON, May 31 (UPI) -- The U.S. Food and Drug Administration has approved a drug similar to a leading human growth hormone and sparked a battle over generic biotechnology drugs.
On Tuesday night the FDA posted its decision on its Web site to approve Omnitrope, a drug that's not being categorized as a generic version of Pfizer Inc.'s Genotropin, but close enough to the original to anger Pfizer.
Omnitrope is made by Sandoz, a unit of Novartis AG.
The FDA has termed it a "follow-on" version of the biotechnology drug.
In the ruling the FDA said it didn't set a precedent for approval of generic biotechnology drugs, a research process using living genetics instead of mixing chemicals, The Wall Street Journal reports.
Pfizer had sued to block the FDA approval.
Although the FDA approved Omnitrope under limited current laws, it said any generic biotechnology drug approvals would come after Congress changes certain laws.
Drug companies say the original drugs are made with proprietary information which makes generic replication impossible without going through the same rigorous testing.
