NEWTOWN, Pa., Nov. 21, 2019 /PRNewswire/ -- STI Pharma, LLC today announced the US launch of Carmustine for Injection, USP: 1 Kit (100mg per Vial & Diluent), a generic version of AVET's (formerly Heritage) BiCNU®. STI received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
STI's Carmustine for Injection is a nitrosourea, which is indicated as a palliative therapy as a single agent or in established combination therapy in the following:
- Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
- Multiple myeloma in combination with prednisone.
- Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs.
- Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.
The active ingredient, Carmustine, is made in the USA. STI's Carmustine for injection utilizes exclusively the original innovator product's API source.
"The launch of Carmustine Injection is an important milestone for STI, representing our first oncology injectable approval," said STI President Frank Mullery. "Our injectable pipeline demonstrates our commitment to expanding access to medicine in key therapeutic areas such as Oncology. I look forward to partnering with our customers across the Hospital and Clinic channels to successfully launch Carmustine."
U.S. sales of Carmustine were approximately $75m for the 12 months ending December 31, 2018 according to IQVIA.
Currently, STI has 2 additional ANDAs pending FDA approval and a robust pipeline representing approximately $400 million in annual sales, according to IQVIA.
About STI Pharma, LLC:
Contact: James Mielke at [email protected]
SOURCE STI Pharma LLC