Lupin gets FDA nod to launch generic Tecfidera

Pharma major Lupin said it got approval from the US Food & Drug administration to sell a generic equivalent to Biogen’s big-selling multiple sclerosis drug Tecfidera.

Tecfidera has annual sales of $3.55 billion in the US, making it one of the biggest drugs in the market.

The generic form of the drug is called Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg.

It can be used to treat patients with relapsing forms of multiple sclerosis.

Multiple sclerosis (MS) is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged.

In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between the brain and the rest of the body.

This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems.

Symptoms include double vision, blindness in one eye, muscle weakness, trouble with sensation, or trouble with coordination.

MS can be progressive or relapsing. In the progressive form, the symptoms build up over time, while in relapsing form, they come and go.