Hyderabad, Dec. 15
AUROBINDO Pharma Ltd has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mirtazapine orally disintegrating tablets (ODT) in 15 mg and 30 mg dosages and tentative approval for 45 mg tablet form.
Mirtazapine ODT is the generic version of Organon's Remeron SolTab and is indicated for the treatment of major depressive disorder. The annual sales of Mirtazapine ODT in the US market are estimated at around $100 million.
In a press release here on Wednesday, the company said it would now be able to sell Mirtazapine orally disintegrating tablets in 15 mg and 30 mg dosages immediately and 45 mg dosage after the expiry of 180 days exclusivity period, which expires in February 2006.
According to the company, many generic players, in spite of having approval for Mirtazapine tablets, find it difficult to develop Mirtazapine orally disintegrating tablets. The company claims that it is one among very few companies that has shown its R&D capability by developing this complicated product.
Further, the company said with this USFDA approval for Mirtazapine ODT, its product portfolio for the US market has widened further and it expects to have significant share in the premium market.