Aurobindo Receives FDA Approval for its line of oral contraceptives, Zumandimine and Lo-Zumandimine.
Published: April 03, 2018
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Zumandimine™ and Lo-Zumandimine™ lines of OC tablets. Aurobindo’s Zumandimine™ and Lo-Zumandimine™ are an AB-rated generic equivalent to the reference listed drugs YAZ® and YASMIN®. Please see table below for each of the following product approvals.
|
Product Name |
Strength |
Brand Equivalent |
| Lo-Zumandimine™ Drospirenone and Ethinyl Estradiol Tablets USP | 3 mg/0.02 mg | YAZ® |
| Zumandimine™ Drospirenone and Ethinyl Estradiol Tablets USP | 3 mg/0.03 mg | YASMIN® |
Zumandimine™ and Lo-Zumandimine™ line of tablets are oral contraceptives indicated for the prevention of pregnancy in women. Lo-Zumandimine™ is also indicated to treat symptoms of premenstrual dysphoria disorder (PMDD) and for the treatment of moderate acne in women at least 14 years old.
The combined products have an estimated market size of $254.5M for the twelve months ending January 2018 according to IMS*.
Zumandimine™ and Lo-Zumandimine™ line of OC tablets represents the latest addition to Aurobindo’s broad line of generic pharmaceuticals. Aurobindo’s product portfolio consists of 310 final approvals, including 35 tentative approvals. There are 104 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT January 2018