Two orphan drugs, Dapsone and Mexiletine, which have been in supply shortage despite their status as essential drugs, have finally found their manufacturers in consignment arrangements.
The Korea Orphan & Essential Drug Center said Thursday that it had concluded agreements with Tai Guk Pharm and Hankook Korus Pharm to have them manufacture Dapsone and Mexiletine, respectively.
Dapsone is an antibiotic to treat leprosy and dermatitis herpetiformis. Mexiletine is an anti-arrhythmic drug that can also address periodic paralysis.
Under the agreements, 1.5 million tablets of Dapsone will be available by the first half of next year and 100,000 capsules of Mexiletine, in the second-half year, the KOEDC said.
Due to the shortage of raw material and its rising cost, the production of Dapsone had been halted this year, with the last output going to the Korea Centers for Disease Control & Prevention. The KCDC and the Korean Dermatological Association have been requesting a stable supply because the drug has no substitute.
Mexiletine has been out of supply in Korea since 2008. The KOEDC has imported a substitute to Mexiletine, but the Korean Society of Cardiology and the Korean Neurological Association have demanded a stable supply, citing a shortage of the drug at the medical fields.
“Under the consignment production agreements with the domestic pharmaceutical manufacturers, we will be able to meet the demand of the medical industry,” the KOEDC said. “We will make continuous efforts to secure a stable local supply of the essential medicines.”