(CNN) The US Food and Drug Administration approved a drug to return sexual desire to some women with low libido, the agency said Friday.

The drug, bremelanotide, sold under the brand name Vyleesi by AMAG Pharmaceuticals, is an injection to be taken before sex. It's intended to treat women who are premenopausal and have hypoactive sexual desire disorder, where a lack of interest in sex may cause significant distress in a woman's life.

It will be available in September, and the company has not yet determined pricing or reimbursement information, according to AMAG spokeswoman Sarah Connors.

"Most women who come into my office have no idea that there's this condition ... and that they are one of millions," said Sheryl Kingsberg, division chief of Behavioral Medicine at University Hospitals Cleveland Medical Center. Kingsberg was involved in the drug's clinical trials and has served as a paid consultant for the companies responsible for its marketing and development, AMAG and Palatin Technologies.

Kingsberg, a clinical psychologist, said that "the impact of sexual dysfunction on a woman's self-esteem, on her body image, on her self-confidence and on her relationship is profound."

Read More