Daily International Pharma Alert

Indian drugmaker Sun Pharmaceutical announced that the FDA has granted final approval for the company’s abbreviated new drug applications for Octreotide acetate injection in vials and ampoules.

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, Sun said.

It is also indicated for the suppression or inhibition of the severe diarrhea and flushing episodes associated with with metastatic carcinoid tumors, the company added.

These generic octreotide injections are bioequivalent to Novartis’ Sandostatin, and will be available in 5-ml multiple-dose vials (0.2 and 1 mg/ml) and 1-ml single-use ampoules (0.05, 0.1 and 0.5mg (base)/ml).