Indoco Remedies announced the receipt of final approval from the USFDA for an Abbreviated New Drug Application (ANDA) for Lofexidine Tablets 0.18 mg to market a generic equivalent of Lucemyra Tablets, 0.18 mg of USWM.
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 (“Product”) in the USA. This exclusivity will begin to run from the date of the first commercial marketing of the product. Indoco intends to launch the product immediately in the USA.
This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa.
This product is indicated for the mitigation of symptoms associated with acute withdrawal from opioids and for the facilitation of the completion of opioid discontinuation treatment.
As per IQVIA Health data, the sales of the product are around $ 15.59 million with an expected growth of 38 per cent.