Mylan Inc. MYL today
announced that its business Mylan Institutional has received final approval
from the U.S. Food and Drug Administration for its Abbreviated New Drug
Application for Tranexamic Acid Injection, 100 mg/mL, packaged in 1,000
mg/10 mL Single-dose Vials. This product is the generic version of Pharmacia &
Upjohn's Cyklokapron Injection, which is indicated for short-term use in
patients with hemophilia to reduce or prevent hemorrhage during and following
oral surgery.Tranexamic Acid Injection had U.S. sales of approximately $17
million for the 12 months ending Sept. 30, 2011, according to IMS Health.
Mylan is shipping this product immediately
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