Gonorrhea is a sexually or vertically transmitted infection secondary to Gram-negative diplococcus Neisseria gonorrhoeae.
It is one of the most common bacterial sexually transmitted infections that may cause pelvic inflammatory disease leading to infertility or ectopic pregnancy.
Most of the infected females are asymptomatic but may present with increased or altered vaginal discharge, dysuria, urethral discharge, abnormal vaginal bleeding, vulval itching or burning, dyspareunia, conjunctivitis and proctitis.
Oral solithromycin may not be a suitable substitute for ceftriaxone plus azithromycin in the first-line treatment of uncomplicated genital gonorrhoea, according to results of the phase III SOLITAIRE-U* trial.
New drug applications approved by US FDA as of 01 - 15 November 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.