Zydus Cadila has received a tentative approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg (US RLD TECFIDERA capsules).
It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Dimethyl Fumarate is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Drug maker Zydus Cadila Thursday said it has received approval from the US health regulator to market cholesterol-lowering drug Atorvastatin Calcium tablets. The Ahmedabad-based group has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 10 mg, 20 mg, 40 mg and 80 mg, Zydus Cadila said in a statement.
The product will be manufactured at its formulations facility at Moraiya, Ahmedabad, it added.
Atorvastatin is used along with a proper diet to help lower bad cholesterol and fats and raise good cholesterol (HDL) in the blood. It belongs to a group of drugs known as statins.
Zydus Cadila said it has also received a tentative approval for Dimethyl Fumarate Delayed-Release Capsules, which is indicated for the treatment of relapsing forms of multiple sclerosis.
Shares of Cadila Healthcare, the listed entity of the group, were trading 1.47 per cent down at Rs 353 per unit on the BSE.