Natco Pharma gets USFDA nod for lenalidomide capsules

The drug maker has received final approval for lenalidomide capsules of 5mg, 10mg, 15mg, and 25mg strengths from the US Food and Drug Administration (USFDA).

The drug company said it has received a tentative approval of the 2.5mg and 20mg strengths. Lenalidomide capsules are used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders.

NATCO, along with its marketing partner Arrow International previously settled the Paragraph IV litigation related to the product with Celgene which sells the product under the brand-name Revlimid. Natco and Arrow shall launch the product on agreed-upon launch dates in the future.

In a separate announcement, the drug maker said that its marketing partner, Breckenridge Pharmaceutical (BPI) has received final approval for its Abbreviated New Drug Application (ANDA) for everolimus tablets generic for Zortress) from USFDA.

Natco's partner BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly. The above strengths of everolimus are indicated in the prophylaxis of organ rejection in kidney transplantation and liver transplantation.

As per industry sales data, Zortress and its therapeutic equivalents had generated annual sales of $162 million during the twelve months ending March 2021 in the US.

Meanwhile, Natco Pharma said that it has initiated Phase-III clinical trial of molnupiravir capsules in India. The trial is initiated to evaluate the efficacy and safety of molnupiravir capsules in mild COVID-19 patients. Natco's clinical trial is planned in 32 hospitals across India.

Natco Pharma manufactures a comprehensive range of branded and generic dosage forms, bulk actives and intermediates for both Indian as well as International markets. The drug maker's consolidated net profit dropped 39.3% to Rs 63.40 crore on 26.3% fall in net sales at Rs 355.20 crore in Q3 FY21 over Q3 FY20.

Shares of Natco Pharma jumped 6.21% to Rs 990.80 on Friday.

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