Approval to Streptomycin Sulfate Injections

NEWS 05/17/1993 Approval to Streptomycin Sulfate Injections
P93-17                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Monica Revelle (301) 443-3285

     The Food and Drug Administration today announced the approval
of a supplemental application that enables Pfizer Inc. to
manufacture streptomycin sulfate injections to treat patients with
tuberculosis.
     This action should end a shortage that started in mid-1991
after the last U.S. manufacturer ceased production.
     HHS Secretary Donna E. Shalala said, "I am gratified by the
way federal agencies and private industry cooperated to fill an
important public health need.  The end of the streptomycin
shortages shows that even major problems can be overcome by goal-
oriented teamwork.   It's the sort of spirit I'd like to see in
action, again and again."
     FDA Commissioner David A. Kessler, M.D., said, "Tuberculosis
is again on the rise, and Pfizer is to be commended for answering
our call for an assured supply of therapies to curb this
resurgence."
     FDA set out to counter the threat of streptomycin shortages as
soon as they became apparent two years ago.  A special task force 
headed by Mary Pendergast, Dr. Kessler's deputy commissioner/senior
adviser, canvassed pharmaceutical manufacturers in the United
States, Europe and Asia to identify a firm to seek approval of this
product for the U.S. market.  In the meantime, the agency took  
steps to make possible emergency imports of streptomycin from
Canada.  Last summer, the Centers for Disease Control and
Prevention agreed to distribute the drug supplied for free by
Pfizer under an investigational new drug application by CDC. 
     FDA's expedited approval of Pfizer's supplemental application
will enable the firm to resume the manufacture of the injectable
formulation of streptomycin sulfate.    
     Reported TB cases in the United States continued to rise in
1992.  After reaching an all-time low of 22,201 cases in l985,
cases reported to CDC climbed to 26,673 -- an increase of 20
percent over the seven-year period and a 1.5 percent increase over
1991.  Evidence from previous years suggests that cases among HIV
infected persons and the foreign born are responsible for much of
the rise.  Increases in recent years in TB cases in U.S. born
children under 5 suggest that since such cases result from recent
infection, increased transmission may also be playing a role.
     CDC guidelines recommend the addition of streptomycin to a
core regimen of isoniazid, rifampin and pryazinamide, to prevent
the emergence of drug resistant TB.  Also, the four-drug regimen
can be more easily administered through directly observed therapy,
since this regimen can be given three times per week from the
beginning of therapy or two times per week after a two-week daily
induction phase.
     FDA and CDC are among the eight Public Health Service agencies
in HHS.
                              ####