Shilpa Medicare Gets FDA Approval For Bortezomib Injection
This is the first 'liquid' injection for Bortezomib, approved for both subcutaneous and intravenous administration by the FDA, the pharmaceutical firm says.
Source: Envato
Shilpa Medicare Ltd. has received an approval for its second new drug application from the United States Food and Drug Administration for its injectable product, known as Bortezomib injection, according to an exchange filing on Tuesday.
The product is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL. This is the first "liquid" injection for Bortezomib, approved for both subcutaneous and intravenous administration by the FDA, the pharmaceutical firm said.
The injection is "ready to use" for subcutaneous administration but has to be diluted for intravenous use. The reference product 'Velcade' is a lyophilised injection, which requires reconstitution prior to administration, it said.
Bortezomib Injection, a proteasome inhibitor, contains bortezomib, which is an antineoplastic agent. The NDA provides for the use of Bortezomib injection for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma, according to the company.
"This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce patient-centric solutions that enhance compliance and ease of administration," Managing Director Vishnukant Bhutada said. "I am very pleased to see that our relentless endeavour and self-belief of investing in various value-added products across different segments have started paying off with monetisation opportunities being created in each of the segments, laying a stronger foundation for the future."
Shares of Shilpa Medicare closed 3.97% higher at Rs 761.65 apiece on the BSE, compared to a 0.02% advance in the benchmark Sensex.
