Indoco Remedies Ltd. has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for lofexidine tablets 0.18 mg, a generic version of lucemyra tablets 0.18 mg.
The US drug regulator has also granted Indoco a competitive generic therapy designation, according to an exchange filing on Wednesday.
As the first approved generic, Indoco is eligible for 180 days of competitive generic therapy exclusivity for its lofexidine tablets in the USA, according to the filings.
Indoco will launch the product immediately in the USA. The first commercial launch marks the start of the exclusivity of the drug, it said. As per IQVIA Health data, the sales of the product are around $15.59 million, with an expected growth of 38%.
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, the company said in the filing.
Shares of Indoco Remedies closed 4.80% higher at Rs 351.50 apiece, compared to a 0.13% rise in the benchmark BSE Sensex.
ONGC To Invest Over Rs 7,800 Crore In OPaL Via Buyback Of Convertible Bonds, Warrants. Read more on Business News by NDTV Profit.