Shilpa Medicare gets USFDA nod for Bortezomib Injection for multiple myeloma
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-08-28 06:27 GMT | Update On 2024-08-28 06:27 GMT
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Karnataka: Shilpa Medicare Ltd has announced the U.S. Food and Food Administration (USFDA) has approved the Company's second NDA [505(b)(2)], injectable product - Bortezomib Injection.
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL).
According to the Company, this is the first “liquid” injection for Bortezomib, approved for both subcutaneous and intravenous administration by the USFDA. The Injection is “ready to use” for subcutaneous administration, offering significant advantages to the health care providers. The Injection has to be diluted for intravenous use.
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