FDA label 8c945283-bb9d-46b8-bc3a-0a85a152ce71

5 WARNINGS AND PRECAUTIONS Arterial and venous thromboembolic disorders may occur with use of MILPROSA. Discontinue MILPROSA and initiate appropriate treatment measures if any of these are suspected. ( 5.1 ) Discontinue MILPROSA use if symptoms worsen in a woman with a history of depression. ( 5.2 ) Discontinue MILPROSA use and initiate appropriate treatment measures for women suspected of having toxic shock syndrome based on signs and symptoms including fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness or a sunburn-like rash on the face and body. ( 5.3 ) Avoid the use of MILPROSA with other vaginal products (such as antifungal products, vaginal lubricants, diaphragms and condoms) because these products may alter progesterone release and absorption from MILPROSA. ( 5.4 ) 5.1 Cardiovascular or Cerebrovascular Disorders Be alert to early signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis in women using MILPROSA. Discontinue MILPROSA if any of these are suspected. 5.2 Depression Observe closely women with a history of depression who use MILPROSA. Discontinue MILPROSA if symptoms of depression worsen. 5.3 Toxic Shock Syndrome Cases of toxic shock syndrome (TSS) have been reported in women using vaginal systems with and without tampon use. No causal relationship between the use of MILPROSA and TSS has been established. Warning signs of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness or a sunburn-like rash on face and body. Discontinue MILPROSA if TSS is suspected. and initiate appropriate medical evaluation and treatment. 5.4 Use of Other Vaginal Products Concomitant use of MILPROSA with other vaginal products (such as antifungal products, vaginal lubricants, diaphragms and condoms) has not been studied; these products may alter progesterone release and absorption from MILPROSA [ see Drug Interactions (7) ]. If possible, avoid use of other vaginal products with MILPROSA.

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular or Cerebrovascular Disorders [see Warnings and Precautions (5.1) ] Depression [see Warnings and Precautions (5.2) ] Toxic Shock Syndrome [see Warnings and Precautions (5.3) ] The most common adverse reactions reported at ≥2% with MILPROSA were headache, vaginal discharge, nausea, breast tenderness, post procedural discomfort, abdominal distension, abdominal pain, pelvic pain, and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in Table 1 reflect exposure to MILPROSA (up to 10 weeks) in 647 infertile women (80% Caucasian, 8% African-American, 5% Hispanic, 5% Asian) in a single prospective, randomized, active concurrently-controlled clinical trial of progesterone supplementation in women undergoing in-vitro fertilization (IVF) in the U.S. [see Clinical Studies (14) ]. Adverse reactions that occurred at a rate greater than or equal to 2% in the MILPROSA treatment group are summarized in Table 1. Table 1: Number and Frequency of Adverse Reactions in Women Treated with MILPROSA in an Assisted Reproductive Technology Study (≥2%) Preferred Term MILPROSA (N=647) Headache 44 (7%) Vaginal discharge 26 (4%) Nausea 25 (4%) Breast tenderness 24 (4%) Post procedural discomfort 24 (4%) Abdominal distension 22 (3%) Abdominal pain 19 (3%) Pelvic pain 19 (3%) Constipation 17 (3%) Additional safety data following exposure to MILPROSA was collected in a multi-center, non-comparative, open-label, single-arm study of women undergoing Assisted Reproductive Technology in the U.S. The population consisted of 254 infertile women 18-34 years of age (83% Caucasian, 7% African-American, 9% Asian,1% American Indian) who were exposed up to 10 weeks. The adverse reaction profile was consistent with previous observations. Adverse reactions associated with other drugs containing progesterone include bloating, mood swings, irritability, and drowsiness.

<table width="75%"><caption>Table 1: Number and Frequency of Adverse Reactions in Women Treated with MILPROSA in an Assisted Reproductive Technology Study (&#x2265;2%)</caption><col width="55%" align="left" valign="middle"/><col width="45%" align="center" valign="middle"/><thead><tr><th styleCode="Lrule Rrule">Preferred Term</th><th styleCode="Rrule">MILPROSA (N=647)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Headache</td><td styleCode="Rrule">44 (7%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Vaginal discharge</td><td styleCode="Rrule">26 (4%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nausea</td><td styleCode="Rrule">25 (4%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Breast tenderness</td><td styleCode="Rrule">24 (4%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Post procedural discomfort</td><td styleCode="Rrule">24 (4%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Abdominal distension</td><td styleCode="Rrule">22 (3%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Abdominal pain</td><td styleCode="Rrule">19 (3%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pelvic pain</td><td styleCode="Rrule">19 (3%)</td></tr><tr><td styleCode="Lrule Rrule">Constipation</td><td styleCode="Rrule">17 (3%)</td></tr></tbody></table>