Indoco Remedies Receives Final ANDA Approval from USFDA for Lofexidine Tablets 0.18 mg with Competitive Generic Therapy Designation

Indoco Remedies Limited has announced the receipt of final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Lofexidine Tablets 0.18 mg. This approval allows Indoco to market a generic equivalent of Lucemyra Tablets, 0.18 mg of USWM, LLC. The company has been granted a Competitive Generic Therapy (CGT) designation by the USFDA and is eligible for 180 days of CGT exclusivity for Lofexidine Tablets, 0.18 mg in the USA. The product will be manufactured at Indoco's facility in Goa, India and is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment. As per IQVIA Health data, the sales of the product are around USD 15.59 million with an expected growth of 38%.