First Generic Generess Launched in US

Mylan today announced the US launch of the first generic version of Warner Chilcott's chewable, low-dose contraceptive, Generess Fe.

One year ago, Actavis agreed to grant Mylan a license to market its generic version of Generess Fe under its pending Abbreviated New Drug Application (ANDA) beginning on April 1, 2015. Mylan’s partner, Famy Care Ltd, has received FDA approval for the ANDA, which was awarded 180 days of marketing exclusivity, and Mylan has immediately begun shipping the norethindrone 0.8 mg, ethinyl estradiol 0.025 mg, and ferrous fumarate 75 mg tablets.

The oral contraceptive had total US sales of approximately $114.7 million in 2014, according to IMS Health.

In addition to preventing pregnancy, the chewable tablets can give women a shorter, lighter, and predictable menstrual cycle.

Some of the most serious side effects associated with Generess Fe include blood clot, stroke, and heart attack, though more common side effects include nausea, headaches, depression, acne, and increased weight.

Some herbal remedies, such as St. John’s Wart, are known to reduce the effectiveness of the drug. Therefore, patients are advised to speak with their health care professionals before taking Generess Fe or its generic version.