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| Exchange Received Time 16/11/2018 09:31:30 Exchange Disseminated Time 16/11/2018 09:31:35 Time Taken 00:00:05 | This is to inform you 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 US$ 3.46 billion.
This is for your information and doing the needful.
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