Jane S. Ricciuti, RPh, MS

Disclosures

January 29, 2004

In This Article

Oral Contraceptives

Ovcon 35
(norethindrone and ethinyl estradiol) Tablets

Manufacturer: Bristol Myers Squibb Company

Drug Approval Classification: Original New Drug Application (Approval Date: 11/14/03)

Indication: Ovcon 35 is an oral, spearmint-flavored contraceptive tablet that can be chewed and swallowed. This new version of Ovcon 35 is indicated for the prevention of pregnancy.

Dosing: The pill may be swallowed whole or chewed and swallowed. If the pill is chewed and then swallowed, women should drink a full glass (8 ounces) of liquid immediately afterwards so that the full dose of medication reaches the stomach and no residue is left in the mouth.

Ovcon 35 is available only in a 28-day regimen. Each package contains 21 round, white tablets, with norethindrone and ethinyl estradiol, followed by 7 reminder green (inactive) tablets to complete a 4-week cycle.

Ovcon 35 (norethindrone and ethinyl estradiol) FDA Talk Paper

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