Boehringer Ingelheim permanently shelves production of clonidine, citing earlier recall and market competitors
One less version of clonidine, the decades-old blood pressure and ADHD drug, is now on the shelves.
Boehringer Ingelheim will discontinue its production of Catapres, telling the FDA the decision was due to both an October recall and a number of copycat drugs already on the market from other manufacturers.
BI, the German pharma giant, voluntarily recalled lots of three different doses of clonidine hydrochloride variant Catapres after an extraneous peak in a dissolution test, the company said at the time.
“We have made the FDA aware that we decided to discontinue future production of Catapres,” a BI spokesperson told Fierce Pharma. “There are generic alternatives of clonidine available, and if a patient has any difficulty getting Catapres, they should contact their healthcare provider to discuss alternate treatment options.”
According to the FDA’s list of drug shortages, other supplies of clonidine products are still intact, and no other BI drugs were on the FDA recall list, Fierce reported. Several manufacturers, including Teva, continue to manufacture versions of clonidine, and BI’s discontinuation isn’t expected to impact the overall supply of the drug.
BI’s troubles aren’t the first time a manufacturer has run into problems related to clonidine, which has been on the market since 1974. In 2016, a Frontida BioPharm plant in Philadelphia picked up a warning letter from the FDA after “knowingly” releasing 27 lots of clonidine HCL tablets despite knowing that API in the drug was possibly contaminated.