MORGANTOWN W.Va. – Mylan Pharmaceuticals announced in a press release on Monday that it has restarted production of tablets at its manufacturing facility in Morgantown to meet the potential for increased demand resulting from potential effectiveness of the product in treating COVID-19.
The product, hydroxychloroquine sulfate tablets, are approved by the U.S. Food Food and Drug Administration (FDA) for the treatment of malaria, lupus erythematosus and rheumatoid arthritis, according to the release.
Officials said in the release that although the product is not currently approved for the treatment of COVID-19, it is listed by the World Health Organization as a drug under investigation for efficacy against the coronavirus. Mylan is also taking steps to initiate production of this product outside the U.S. in the coming weeks. The release stated that Mylan is looking forward to working with governments and health authorities globally to ensure patient access to the medicine as and where needed.
The release also stated that Mylan expects to be in a position to begin supplying the product by mid-April, and with the active pharmaceutical ingredient that it currently has available, 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.
The release stated that the growing threat of COVID-19 requires a commitment by everyone involved in public health. Mylan officials said the company takes its responsibility seriously and is committed to continuing to work with governments, partners and others to identify areas of need where the company’s global R&D, regulatory and manufacturing expertise and capacity can be of service.