NEWS
01/05/1993

<TITLE>Concern about the supply of Parke-Davis & Co.'s Nitrostat</TITLE>
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P93-3                                        Food and Drug Administration
FOR IMMEDIATE RELEASE                        Susan Cruzan - (301) 443-4177

    The Food and Drug Administration has been receiving inquiries expressing  
concern about the supply of Parke-Davis & Co.'s Nitrostat, a nitroglycerin    
tablet that is dissolved under the tongue for treatment of acute angina.      
Warner-Lambert, which owns Parke-Davis, has reported that problems with new   
manufacturing processes for the drug may have temporarily disrupted           
distribution of the drug in certain strengths to some outlets.
    Although spot shortages have occurred, the company is quickly             
resupplying pharmacies, and no public health problems are anticipated.        
According to reports the agency has received, production problems with this   
product have been resolved, and full distribution has now resumed.  
    The company has released an additional 300,000 bottles of Nitrostat in    
the 0.3 and 0.4 milligram strengths, which should take care of any backlogs   
and provide an adequate supply of the drug throughout the country by Tues.,   
Jan. 12.  Warner-Lambert has informed doctors and pharmacists of the status   
of the distribution and is sending an additional letter to pharmacists today  
with more details.  The company is shipping the product by air freight to     
its distributors, and has established a mechanism to ensure availability to   
all pharmacies.
    In the meantime, patients should obtain the drug in normal quantities     
only, to ensure adequate supplies for all.  Pharmacists should use prudence   
in filling large requests.  Substitution of lower-strength tablets may be     
made in some cases where higher-strength tablets are unavailable.  Patients   
with questions about this matter should consult their physician or            
pharmacist. 
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