Lupin obtains FDA OK for generic Depen

Patients with Wilson’s disease, Cystinuria, and severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy will soon have a new generic treatment.

The Food and Drug Administration has given the green light to Lupin for penicillamine tablets in a dosage strength of 250 mg.

The product is the generic of Mylan Specialty’s Depen tablets.

It will be manufactured at Lupin’s Nagpur facility and is expected to be launched shortly.

Depen had a market value of approximately $4 million, according to September 2020 IQVIA data.