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FDA Approvals

CCRStudies in New London is proud to have participated in a series of clinical trials resulting in the approval of a variety of medications through the Food and Drug Administration (FDA). Some of the medications tested at CCRStudies now available on the market include those listed below. Click on the press release links to read more about these medications.

OSPHENA – a treatment for moderate to severe painful intercourse, a symptom of changes in and around the vagina due to menopause

http://www.fda.gov/NewsEvents/Newsroom

/PressAnnouncements/ucm341128.htm

PRISTIQ –a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause

https://www.drugs.com/history/pristiq.html

GILENYA –for the treatment of patients with relapsing forms of multiple sclerosis

https://www.drugs.com/history/gilenya.html

BRISDELLE – a non-hormonal prescription treatment option for moderate to severe hot flashes associated with menopause

http://www.fda.gov/newsevents/newsroom/

pressannouncements/ucm359030.htm

FARXIGA– a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes

http://www.fda.gov/NewsEvents/Newsroom

/PressAnnouncements/ucm380829.htm

SEASONIQUE – a tablet for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception

http://www.prnewswire.com/news-releases/fda-approves-durameds-seasoniquetm-

extended-cycle-oral-contraceptive-companys-second-proprietary-extended-cycle-oc-to-be-available-in-july-56561282.html

VESICARE – a medication for overactive bladder with symptoms of urgency, frequency, and leakage

http://www.webmd.com/urinary-incontinence-oab/news/20041123/vesicare-approved-to-treat-overactive-bladder

RECLAST – for the treatment of osteoporosis

http://www.fiercebiotech.com/press-releases/press-release-novartiss-reclast

-receives-fda-approval-women-postmenopausal-osteoporos

VAGIFEM– a tablet that treats the underlying cause of menopause-related vaginal changes

http://press.novonordisk-us.com/index.php?s=20295&item=122584

DUAVEE – for the treatment of moderate to severe vasomotor symptoms associated with menopause

and the prevention of postmenopausal osteoporosis

SANCTURA – indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/862/sanctura-trospium-chloride

ADDYI (Flibanserin) – the first medication to be approved by the FDA to treat women for HSDD – Hypoactive Sexual Desire Disorder

http://www.fda.gov/NewsEvents/Newsroom/

PressAnnouncements/ucm458734.htm

BIJUVA (estradiol and progesterone) – the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

https://www.news-medical.net/news/20181029/TherapeuticsMD-announces-FDA-approval-of-BIJUVA-capsules-to-manage-vasomotor-symptoms-of-menopause.aspx

VYVANSE – for the treatment of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder

https://www.drugs.com/history/vyvanse.html

ORILISSA- for the treatment of moderate to severe pain associated with endometriosis

https://www.fda.gov/Drugs/InformationOnDrugs/ucm616534.htm

TOVIAZ –indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

https://www.drugs.com/history/toviaz.html

DIVIGEL – for the treatment of moderate to severe vasomotor symptoms (hot flashes/night sweats) associated with menopause

https://www.medscape.org/viewarticle/558654

VICTOZA – indicated to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of heart attack, stroke and CV death in adults with type 2 diabetes and established CV disease

https://www.drugs.com/history/victoza.html

IMVEXXY– for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause

https://www.prnewswire.com/news-releases/therapeuticsmd-announces-fda-approval-of-tx-004hr-imvexxy-estradiol-vaginal-inserts-the-lowest-dose-vaginal-estrogen-product-approved-for-the-treatment-of-moderate-to-severe-dyspareunia-a-symptom-of-vva-due-to-menopause-300656468.html