Natco Pharma gets approval for Everolimus tablets for Oral Suspension for subependymal giant cell astrocytoma

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-01-30 06:00 GMT   |   Update On 2025-01-30 07:04 GMT

HyderabadNATCO Pharma Limited, an Indian pharmaceutical company, has announced the approval of its Abbreviated New Drug Administration (ANDA) for Everolimus tablets for oral suspension (TFOS), 2mg, 3mg and 5mg, a generic version of AFINITOR DISPERZ by Novartis Pharmaceutical Corporation.

NATCO’s marketing partner for the ANDA, Breckenridge Pharmaceutical, Inc plans to launch the product immediately in the US market.
Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex (“TSC”) for the treatment of subependymal giant cell astrocytoma (“SEGA”) that requires therapeutic intervention but cannot be curatively resected.
Everolimus tablets for oral suspension (TFOS), 2mg, 3mg and 5mg, had estimated sales of USD 112 million in the U.S. for 12 months ending Sep’24 as per industry sales data.
Medical Dialogues team had earlier reported that Natco Pharma had announced the submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (USFDA) for the generic version of EVRYSDI (Risdiplam) 0.75 mg/mL For Oral Solution. 

Read also: Natco Pharma submits application with USFDA for Risdiplam for Oral Solution

NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.

Read also: Natco Pharma appoints Madhava Rao Karicherla as Associate Vice President - Formulation RnD, Pharma Division, Kothur Unit

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