![]() Up to 24 hours, no matter how many times intercourse occurs. It is moistened with tap water prior to use and insertedĭeep into the vagina removal is achieved by pulling the attached loop. Made of polyurethane, it contains 1,000 mg of the spermicide In shape, two inches in diameter, and three-quarters of an inch thick, withĪn attached loop. The FDA also may elect to perform a preapproval inspectionįor manufacturing compliance at the OSG Norwich site, which has an "excellent" Is to change the manufacturing plant to the OSG Norwich site.Ĭompany has product stability material ready for the FDA’s review, which is Which has been submitted to the FDA for its review, says Staab. (NDA) for the sponge remains active however, Allendale Pharmaceuticals must Required to move the company’s request forward? Still is under review, confirms Susan Cruzan, FDA spokeswoman. In repeated delays and a switch from a contract manufacturer in Mainland, PA, Tougher new FDA standards for manufacturing and record keeping resulted Originally planned to reintroduce the sponge in the American market in fall Allendale Pharmaceuticals acquired manufacturing and marketing rights Problems caused by water quality issues at the old factory where the sponge Of New York City, ceased production when it determined it cost too much to correct The sponge from the market its former manufacturer, Whitehall-Robins Healthcare Of the sponge’s re-emergence some 250 million sponges were sold between Today’s While the sponge is not for sale in the United States,Īmerican women are ordering the device from the Canadian web sites. equivalent of about $2.90Įach on the two web sites. He predicted it would be on Canadian pharmacy shelves and other mass-merchandising At Contraceptive Technology Update press time, see vaginal contraceptive?įDA approval for marketing in United StatesĪnnouncement to revive the Today contraceptive sponge, the company responsibleįor its rebirth finally has released the product in Canada and says it is pressingįor Food and Drug (FDA) approval to market the device over the counter in theįor sale over the Internet on two Canadian web sites, and says Robert Staab, PhD, chairman and chief scientific officer of Allendale Finally, Allendale Pharmaceuticals decided to give the sponge another shot, and it's now available once again in drugstores.In Canada - will U.S. Even though nothing was wrong with the sponge itself, production stopped, causing a slew of women to go into frantic sponge-hoarding mode (like Elaine on Seinfeld). Side note: The sponge was introduced onto the market in 1983 and sold steadily for 11 years-12 percent of women ages 15 to 44 used it at some point-until the FDA decided that the factory making it didn't meet safety standards. And because it must be left in for six hours, it can become brittle and fall apart when removed.Īlso, some women and men experience allergic reactions to certain spermicides and should consult a health-care professional if symptoms like a rash, respiratory distress, or swelling develop after use. For starters, you hold it under a faucet and squeeze until the nonoxynol-9 gets sudsy, then make sure it's properly positioned around the cervix. The biggest complaint from sponge users is the mess factor. This is because the vaginal muscles are different in women who have given birth. The one-gram sponge is 84 to 91 percent effective in preventing pregnancy in women who have never given birth, and 68 to 80 percent effective in women who have given birth. No hormones are involved, so body chemistry and fertility isn't affected. ![]() The sponge should be left in place for at least six hours after intercourse, but not left in for more than 30 hours. When moistened with water and placed into the vagina, the sponge releases the spermicide and begins working right away and for the next 24 hours.
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