Camargo Pharmaceutical Services announced that the company has helped California-based innovative nonprofit global women's health pharmaceutical company, Medicines360 to gain US 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."

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.

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.