CINCINNATI, Ohio, Jan. 18, 2016 /PRNewswire/ -- Camargo Pharmaceutical Services, the most experienced global strategist in the drug development industry specializing in the 505(b)(2) approval pathway, has helped Medicines360 gain FDA approval for their hormonal intrauterine contraceptive device.
"2015 was a very successful year: our (Medicines360) first NDA was approved and Camargo played a crucial role in this," said Andrea Olariu MD, PhD, Chief Medical Officer for Medicines360.
Medicines360's mission is to expand access to medicines for women regardless of their socioeconomic status, insurance status, or geographic location.
Medicines360's first approved product is a levonorgestrel-releasing intrauterine system (IUS), 52 mg. This IUS is a high quality product which will reach underserved women in 340B family planning clinics because it is being made available to these clinics at an affordable price of $50.
"We look forward to our continuing work with Medicines360 as they develop women's health products," said Ruth Stevens, PhD, MBA, Chief Scientific Officer and Executive Vice President at Camargo Pharmaceutical Services. "Our expertise in the 505(b)(2) approval pathway and drug development process is a great match for Medicines360 in helping them bring their products to market in a cost- and time-effective manner."
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure FDA buy-in every step of the way. Camargo routinely holds three to six pre-IND meetings a month, has over 200 FDA approvals and a 95% FDA concurrence rate, and works with product developers across more than 25 countries. Connect with Camargo on LinkedIn, read the company blog, and visit camargopharma.com for more information.
Medicines360, located in San Francisco, California, is an innovative nonprofit global women's health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org
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SOURCE Camargo Pharmaceutical Services