Biocon Gets USFDA Approval for Everolimus Oral Suspension in Pediatric, Adult TSC
Written By : sheeba farhat
Published On 2026-01-12 17:45 GMT | Update On 2026-01-12 17:45 GMT
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Bengaluru: Biocon Limited on Monday said its wholly owned subsidiary, Biocon Pharma Limited, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension.
According to the regulatory filing, the approval covers 2 mg, 3 mg and 5 mg strengths of Everolimus Tablets for Oral Suspension. The product is indicated for the treatment of adult and pediatric patients aged one year and above with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA).
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