FDA clears Cipla’s Tecfidera generic

Cipla’s latest generic has been approved by the Food and Drug Administration. The company’s generic of Tecfidera (dimethyl fumarate DR) capsules have passed regulatory muster in two dosage strengths. 

The product is indicated to treat relapsing forms of multiple sclerosis. Cipla’s generic is available in 120 mg and 240 mg dosage strengths, as well as in a 120 mg/240 mg Starter Pak. Cipla said the product would be available for shipping immediately. 

For the year ended July 2020, IQVIA data showed U.S. sales of roughly $3.8 billion for the drug.