The approvals are for American Pharmaceutical Partners’ (APP) abbreviated new drug applications (ANDAs) for octreotide acetate injection, single-dose and multiple dose vials.
Octreotide acetate injection is indicated for the treatment of agromegaly (excessive secretion of growth hormone). Octreotide is also used to reduce flushing and watery diarrhea caused by metastatic cancerous tumors or vasoactive intestinal peptide tumors.
“Octreotide acetate is used in the critical care as well as the oncology setting,” said Dr Patrick Soon-Shiong, chairman and CEO of APP. “These two approvals mark the first two product approvals APP has received in 2006.”
The full line of Octreotide products will be available from APP in single-dose vials and multiple-dose vials. APP said it expects to commence marketing the product shortly.
This will not come as welcome news to Novartis, which saw Sandostatin sales decline in the US and remain flat globally in 2005. However, the company’s long-acting LAR version of the drug has seen good sales growth, giving Novartis something to help counter generic competition for the moment at least.