Glenmark Pharma has been granted final approval by
the United States Food and Drug Administration (USFDA)
for Dimethyl Fumarate delayed-release capsules
in the strengths of 120 mg and 240 mg. They are
used for the treatment of relapsing forms of multiple
sclerosis in adults. This is the most common form of
About 75% to 85% of people with multiple sclerosis are
initially diagnosed with relapsing forms of multiple sclerosis.
People with RRMS have temporary periods called relapses,
flare-ups or exacerbations, when new symptoms appear.
Glenmark said Tecfidera delayed-release capsules achieved
annual sales of approximately USD 3.8 billion in the market.
Glenmark Pharmaceuticals NSE -0.36 % Inc., USA, said that
current portfolio consists of 164 products authorised for
distribution in the US marketplace and 46 abbreviated new
drug applications are pending approval with the USFDA.