New Delhi: Shilpa Medicare has recently received tentative approval from the US health regulator for Dimethyl Fumarate delayed-release release capsules, used for the treatment of relapsing forms of multiple sclerosis.
Dimethyl Fumarate Delayed-Release Capsules 120 mg & 240 mg is a generic of Tecfidera used in the treatment of patients with relapsing forms of multiple sclerosis.
This ANDA is a first to file submission made on NCE-l dated March 27, 2017. FDA review process was completed and got approval within a period of 19.5 months from the date of submission.
According to IQVIA MAT Q2 2018 data, the US market for Dimethyl Fumarate DR Capsules is approximately US$ 3.46 billion.