The Food and Drug Administration on Friday approved U.S. sales of the sponge, which was a popular nonprescription birth control product among women when it was withdrawn from the market in 1995.
Now the polyurethane sponges, which manufacturer Allendale Pharmaceuticals has sold in Canada and over the Internet since March 2003, will be available shortly in the U.S. through a company Web site.
Soon after that, the product will be available at retail drug chains, followed by supermarkets and mass marketers such as Wal-Mart, Allendale said.
Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, Wyeth Co. of Madison. Wyeth, then called American Home Products, had stopped making the sponge rather than upgrade its Hammonton manufacturing plant after FDA found deficiencies there, even though the device's effectiveness and safety were never questioned.
"I'm overwhelmed," Gene Detroyer, president and chief executive officer of Allendale Pharmaceuticals, told The Associated Press. "I am pleased both from a business point of view ... and from the point of view that we can add another contraceptive for women."
FDA spokeswoman Susan Cruzan confirmed the approval.
"They can re-enter the U.S. market," she said. "The product was found to be safe and effective."
The Today Sponge, a soft, concave device, prevents pregnancy by covering the cervix and releasing spermicide. Roughly 250 million sponges were sold from 1983 to 1995.
While it was less effective than several other methods and does not protect against sexually transmitted diseases, the sponge achieved a wide following among women who saw advantages from spontaneity to wide availability.
The product's 1995 withdrawal sparked a hilarious sendoff on the sitcom "Seinfeld," in which character Elaine Benes coined the term "spongeworthy." Like many real women, Elaine scoured pharmacies until she found a case of her favorite birth control. She then stretched her supply by setting "spongeworthy" standards for prospective lovers.
In Canada, where the original Today Sponge was only on the market about 18 months, more than 400,000 sponges have been sold through retail outlets and Internet sites since they were approved for sale there two years ago.
Detroyer plans an advertising campaign for the U.S. market and expects sales to jump to 10 million to 15 million sponges in the first 12 months. That's the current production limit of the company's factory in Norwich, N.Y., but the company has plans to double that.