Aurobindo Pharma gets final approval of Mirtazapine ODT 45 mg for U.S. market

By Elaine Rigoli

Tampa, Fla., March 2 - Aurobindo Pharma Ltd. has announced that the Food and Drug Administration has granted final approval for the company's Mirtazapine Orally Disintegrating Tablet (ODT) 45 mg.

Mirtazapine is indicated for the treatment of major depressive disorder, according to a company news release.

Last year, the company received tentative approval for Mirtazapine ODT 45 mg because of 180-day exclusivity by other generic companies.

Aurobindo already had been granted final approval for Mirtazapine ODT 15 mg and 30 mg.

With this final approval, the company will be able to sell Mirtazapine ODT 45 mg apart from 15 mg and 30 mg, the release said.

Mirtazapine ODT is the generic version of Organon's Remeron SolTab, the release said.

Annual U.S. sales of Mirtazapine ODT tablets are about $100 million.

Aurobindo manufactures generic pharmaceuticals and is located in Hyderabad, India.

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