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Alembic Pharmaceuticals Limited (Alembic) today an
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The company has received approval from the United States Food and Drug Administration (USFDA) to advertise its own Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg, Lupin said in a statement.
The item is a generic version of Biogen Inc”s Tecfidera delayed-release capsules at the same strengths, it added.
The company hopes to launch the product shortly, the announcement said.
According to the IQVIA MAT June 2020 data, Dimethyl Fumarate delayed-release capsules had an annual sales of approximately USD 3,788 million in the US, Lupin said.
The capsules are suggested,”for the treatment of patients with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and lively secondary progressive disease, in adults,” it added.
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