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RAPAMUNE (nda021083)- (1MG/ML)

SIROLIMUS PF PRISM CV
1MG/ML
No No
2014-Mar-30 Expired
2022-May-28 None
None No
• Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation. o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation. Safety and efficacy of CsA withdrawal has not been established in high risk patients. • Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis.
6 0 5
Total Other Developers 5
Drugs with Suitability No
1MG/ML ** ** - - 4
NDA Sales Available Total Generic Sales Available
Yes 4
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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