Shilpa Medicare Ltd has recently informed the exchanges that the USFDA has approved its second NDA [505(b)(2)], injectable product, Bortezomib Injection.
Bortezomib Injection is approved for subcutaneous and intravenous use. It comes in a single dose vial with 3.5 mg/1.4 mL (2.5 mg/mL).
In the filing, the company shared, “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. The reference product Velcade® is a lyophilized injection which requires reconstitution prior to administration.”
The statements further read that Bortezomib Injection, a proteasome inhibitor, includes bortezomib, an antineoplastic agent. This NDA provides the use of Bortezomib injection for the treatment of adult patients with multiple myeloma and mantle cell lymphoma.
In the meantime, as of 2:02 pm, the shares of Shilpa Medicare were trading 4.98% higher at Rs 768.00 on NSE.
