New Oral Contraceptive Approved
November 10, 2016 – The US FDA approved the first oral contraceptive to be manufactured as soft gelatin capsules instead of tablets. Taytulla™ (norethindrone/ethinyl estradiol/ferrous fumarate), manufactured by Allergan, is Indicated to prevent pregnancy and is now available on the market. Each 28-day pack contains four inactive maroon-colored capsules to be taken after 24 pink capsules each containing 1mg of the progestin (norethindrone), 20mcg of estradiol and an iron supplement. It is intended to be taken every day with no days off between packs. A boxed warning on all oral contraceptives, including Taytulla, cautions about the increased risk of adverse cardiovascular effects, such as blood clots, for women who smoke while taking an oral contraceptive. Smokers over the age of 35 years should not use any of them.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and 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.