Indoco Remedies stock surged up to 5.53 per cent at Rs 358.60 per share on the BSE in Wednesday’s intraday deals. This came after the company disclosed that it has received a final approval from the United States Food and Drugs Administration (USFDA) for its new drug application.
The Mumbai-based pharmaceutical received the top US regulator’s nod to market Lofexidine Tablets 0.18 mg, a generic equivalent of Lucemyra Tablets, 0.18 mg of the US-based drugmaker US WorldMeds.
This drug is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment.
According to IQVIA Health data, the sales of the product are around $15.59 million with an expected growth of 38 per cent.
“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,” the company said in an exchange filing.
The 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 – 403722 in India.
“We are extremely pleased with this development as this strengthens our…
