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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

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

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

http://www.fiercebiotech.com/press-releases

/press-release-indevus-pharmaceuticals-announces-fda-approval-sanctura

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

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