Posted from: Wednesday, April 29, 2015 - 11:29 AM - Present

Generic Generess Fe Approved for Contraception

April 1, 2015 – The U.S. Food and Drug Administration (FDA) approved norethindrone/ethinyl estradiol tablets 0.8mg/0.025mg and ferrous fumarate tablets 75mg, manufactured by Mylan.  Mylan began shipping is medication shortly after approval. The generic for Generess Fe (Warner-Chilcott, now a part of Actavis), is indicated for women choosing an oral contraceptive method to prevent pregnancy. The low-dose tablets are chewable and taken without water, making them easier to use for women who have trouble swallowing. Mylan has 180 days of exclusivity. During the calendar year of 2014, sales of Generess Fe amounted to $114.7 million in the U.S., according to IMS Health.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, October 11, 2019 - 07:05 PM.