US FDA approves Sun Pharma’s  generic Octreotide injectionin vials and ampoules

Sun Pharmaceutical Industries Ltd, has received final approval from US FDA for it’s multiple Abbreviated New Drug Applications (ANDAs) for Octreotide acetate injection in vials and ampoules. This is the second injectable approval from the plant in Halol, India. The company expects to reach the market shortly with these products.

Octreotide acetate is indicated to reduce blood levels of growth hormone and IGF-I in acromegaly patients who have inadequate response or cannot be treated with other methods. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Yet another use is the treatment of profuse watery diarrhea associated with VIP secreting tumors.

These generic octreotide injections are bioequivalent to Sandostatin®, a registered trademark of Novartis and will be available in 5 ml multiple-dose vials (0.2 mg/ ml and 1 mg/ml) and 1 ml single-use ampoules (0.05 mg (base)/ml, 0.1mg (base)/ml, 0.5mg (base)/ml). These strengths of octreotide generic and branded products had annual sales of approximately USD 100 million in the US.