Vaginitis is an inflammation of the vagina. It often is caused by infections, some of which are associated with serious diseases. The most common vaginal infections are
*Bacterial vaginosis(BV)
*Trichomoniasis
*Vaginal yeast infection
Some vaginal infections are transmitted through sexual contact, but others, such as yeast infections, probably are not.
Bacterial vaginosis is a condition in women that is characterized by vaginal discharge and results from an overgrowth of bacteria in the vagina. Bacterial vaginosis (BV) is the most common cause of vaginal infection (vaginitis). For grammatical reasons, some people prefer to call it vaginal bacteriosis.The most common symptom of BV is an abnormal vaginal discharge with an unpleasant fishy smell. However, nearly half of all women with BV don't notice any symptoms.
Health care providers use antibiotics such as metronidazole or clindamycin/tetracycline to treat women with BV. Generally, male sex partners will not be treated.
The Food and Drug Administration today approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a treatment for bacterial vaginosis. The approval is an important step in the agency's effort to increase the availability of lower-cost generic medications.
"This approval is another example of our agency's efforts to increase access to safe and effective generic versions of approved brand name drugs as soon as the law permits," said Gary J. Buehler, Director, and Office of Generic Drugs. "Metronidazole vaginal gel is a widely-used antibacterial preparation, and its generic version can bring significant savings to the millions of Americans with bacterial vaginosis." Metronidazole is an antibiotic effective against anaerobic (lacking oxygen) bacteria.
The economic benefits of FDA's generic drug approval program are significant because generic drug products are used to fill over 50 percent of all prescriptions and can cost a fraction of the price of the brand name drugs. Competition from generic drugs that are safe and effective alternatives may quickly lead to reductions in spending.
The Office of Generic Drugs works expeditiously to review and take action on generic drug applications as quickly as possible. The same thorough and rigorously scientific review standards of safety, efficacy and quality are applied to generic drug applications as are applied to new drug applications. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to the brand name drug and is its equal in dosage form, strength, and route of administration, quality, performance characteristics, and intended use.
Metronidazole Vaginal Gel, 0.75 %, is manufactured by QLT USA, Inc. in Fort Collins, CO. QLT challenged certain patents for the listed drug MetroGel-Vaginal and is eligible for 180 days of generic drug exclusivity. The FDA may approve other applications after the exclusivity period has expired.
In most cases, BV causes no complications. There have been documented risks of BV, however, such as an association between BV and pelvic inflammatory disease (PID). PID is a serious disease in women which can cause infertility and tubal (ectopic) pregnancy.
BV also can cause other problems such as premature delivery and low-birth-weight babies. Therefore, some health experts recommend that all pregnant women, whether or not they have symptoms, who previously have delivered a premature baby be checked for BV. A pregnant woman who has not delivered a premature baby should be treated if she has symptoms and laboratory evidence of BV.
BV also is associated with increased chances of getting gonorrhea or HIV infection. (HIV, human immunodeficiency virus, causes AIDS.)
| 
| 195 : vote(s) so far
| Cast your vote: