Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

NEW DELHI: Drugmaker Indoco Remedies Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Lofexidine tablets, used in opioid discontinuation treatment, with 180 days of competitive generic therapy exclusivity.

The approval by the US Food and Drug Administration (USFDA) is for Lofexidine tablets 0.18 mg, a generic equivalent of Lucemyra tablets, 0.18 mg of USWM, LLC, Indoco Remedies said in a regulatory filing.

"Indoco has been granted a Competitive Generic Therapy (CGT) designation by the USFDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for Lofexidine tablets, 0.18 mg in the USA," it added.