Indoco Remedies spurts on receiving USFDA nod for Lofexidine tablets

Indoco Remedies gained 4.61% to Rs 350.85 after the firm received final approval from the US Food and Drug administration (USFDA) for its abbreviated new drug application (ANDA) for Lofexidine Tablets.

The generic equivalent of Lucemyra Tablets will market to USWM, LLC.

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. 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, it added.

Lofexidine Tablets is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment. The product will be manufactured by the company at its manufacturing facility located at Goa.

As per IQVIA Health data, the sales of the product are around $15.59 million with an expected growth of 38%.

Aditi Panandikar, MD, 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 US.

Indoco is a fully integrated, research-oriented pharmaceutical company. The company has 11 manufacturing facilities, 7 for FDFs and 4 for APIs, supported by an R&D Centre and a CRO facility.

Indoco Remedies consolidated revenue grew by 1.8% YoY to Rs 424.29 crore while the profit after tax declined by 89.3% YoY to Rs 2.62 crore in Q1 FY25 over Q1 FY24.

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