Aurobindo obtains FDA nod for 2 generics

Aurobindo has received permission from the Food and Drug Administration for two generic drugs.

The first drug approval is for dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, which is the generic of Biogen’s Tecfidera.

[Read more: Aurobindo receives FDA approval for 3 generics]

Dimethyl fumarate delayed-release capsules, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis, have a market value of roughly $771 million for the 12 months ending November 2022, according to IQVIA.

Aurobindo also has received the FDA’s nod for lacosamide tablets in dosage strengths of 50 mg, 100 mg, 150 mg and 200 mg.

The medication is the generic of UCB’s Vimpat. It is indicated as monotherapy or adjunctive therapy in patients with partial-onset seizures.

[Read more: Aurobindo obtains FDA OK for 2 generics]

Lacosamide tablets have a market value of roughly $971 million for the 12 months ending November 2022, according to IQVIA.