Indoco Remedies receives FDA OK for generic Lucemyra
Indoco has gained permission from the Food and Drug Administration for lofexidine tablets 0.18 mg, which is a generic of USWM’s Lucemyra Tablets.
Indoco has been granted a Competitive Generic Therapy designation by the FDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for lofexidine tablets, 0.18 mg.
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 United States.
[Read more: What is the state of the generics industry?]
This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.
Generic Lucemyra is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment.
The product has a market value of roughly $15.6 million with an expected growth of 38%, per IQVIA.
Aditi Panandikar, managing director of Indoco said, “We are extremely pleased with this development as this strengthens our position in the US market, driving us closer to expanding our reach in the U.S.”
[Read more: Indoco Remedies obtains FDA OK for generic Zyprexa]