USFDA accepts Panacea Biotech’s ANDA for breast cancer drug
New Delhi: Drug firm Panacea Biotech on Thursday confirmed that the US Food and Drug Administration (FDA) has accepted its abbreviated new drug application (ANDA) to evaluate its dossier for marketing paclitaxel protein-bound particles for injectable suspension (100 mg per vial) in the US.
The product is a generic version of abraxane, which is indicated for the treatment of metastatic breast cancer, non small cell lung cancer and adenocarcinoma of the pancreas in the US market.
The product is already commercialized in India and emerging markets like Sri Lanka, Turkey under the trademark PacliAll. PacliAll is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for the metastatic disease.
Panacea Biotec joint managing director Rajesh Jain said, “The FDA’s acceptance of our ANDA filing is an important milestone for their ‘Best-few’ products development program and oncology portfolio as a whole. This ANDA filing acceptance gives us confidence in the strong understanding of science of developing such complex products at each level in the company, right from R&D to Operations, to ensure sustainable performance in years to come.”
As per the company, clinical trials were conducted on 96 patients and showed results equivalent to innovator abraxene. The PacliAll regimen used in the study was injectable suspension in a dose of 260 mg /m2 administered intravenously over 30 minutes every three weeks. The product comes with an added advantage, said Jain. “The clinicians can adjust dosages and this doesn’t cause neurological toxicity and hair loss,” he said.
The annual sale of abraxane worldwide is worth approximately $973.4 million and approximately $633.8 million in the US.
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