India, Jan. 12 -- Biocon Ltd on Monday said its subsidiary Biocon Pharma Ltd has received approval from the US Food and Drug Administration (USFDA) for its generic Everolimus tablets for oral suspension.
The approval has been granted for the Abbreviated New Drug Application (ANDA) covering Everolimus tablets for oral suspension in 2 mg, 3 mg and 5 mg strengths, the company said in a regulatory filing.
Everolimus is used in the treatment of tuberous sclerosis complex, a rare genetic disorder that leads to the development of non-cancerous tumours or lesions in various parts of the body.
Biocon said the approval will further strengthen its vertically integrated portfolio of drug products, enhancing its presence in the regulated US generics ...