On 28 Jan. 2020, USFDA approved Sun Pharma’s Bynfezia (Octreotide acetate subcutaneous injection). Previously, Sun has also received ANDA approval for generic Sandostatin.
Indications and dosing of Bynfezia are same as that of Sandostatin. The amount of preservative in 1 ml of Bynfezia is same as that of Sandostatin. However, the concentration of Octreotide in Bynfezia is higher than Sandostatin; hence, Bynfezia requires lower volume to deliver the equivalent dose of Octreotide and correspondingly, the amount of preservative injected will be also less.
Additionally, Sandostatin is available only as Multi dose vials while Bynfezia will be supplied in pre-filled pen devices.
Comparison between Bynfezia and Sandostatin is available below:
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