Aurobindo wins approval for rhuzdah

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for rhuzdah (norethindrone and ethinyl estradiol tablets, USP), 0.4 mg/0.035 mg.

Rhuzdah is an AB-rated generic equivalent to the reference listed drug Ovcon-35, manufactured by Warner Chilcott Company, LLC. It is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

The product had estimated sales of  $536,000 for the year ended August 2022, according to IQVIA.


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