To help address public health needs amidst the evolving COVID-19 pandemic, Mylan has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility in the U.S. to meet the potential for increased demand resulting from potential effectiveness of the product in treating COVID-19.
 
Mylan’s hydroxychloroquine sulfate tablets are approved by the U.S. FDA for the treatment of malaria, lupus erythematosus and rheumatoid arthritis. Although the product is not currently approved for use in the treatment of COVID-19, it is listed by the World Health Organization as a drug under investigation for efficacy against the coronavirus. The company is also taking steps to initiate production of this product outside the U.S. in the coming weeks.
 
Mylan expects to be in a position to begin supplying product by mid-April, and with the active pharmaceutical ingredient (API) that is currently available, says it will be able to ramp up manufacturing to provide 50 million tablets to potentially treat a total of more than 1.5 million patients. The potential use of this medicine for COVID-19 related treatment is pending additional FDA and other regulatory body guidance.