OSPHENA is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

OSPHENA is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin [see WARNINGS AND PRECAUTIONS].

Use of OSPHENA should be for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

Take one 60 mg tablet with food once daily.

Dosage Forms And Strengths

OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with “60” on one side.

OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with “60” on one side. They are available as follows:

NDC 59630-580-10 Bottle of 100 tablets
NDC 59630-580-30 Blister pack of 30 tablets containing 2 blister cards of 15 tablets each

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Penn Pharmaceutical Services Ltd. 23-24 Tafarnauback Industrial Estate Tredegar, Gwent, South Wales NP22 3AA, United Kingdom Made in UK. Approved: February 2013

Last reviewed on RxList: 3/18/2013
This monograph has been modified to include the generic and brand name in many instances.