Shilpa Medicare has informed that the Company's ANDA (210291) for Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg has been granted tentative approval by FDA. 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-1 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 $3.46 billion.
The above information is a part of company’s filings submitted to BSE.
