TRENTON, N.J. - The Today Sponge contraceptive is returning to the market after a decade as federal regulators Friday deemed it "spongeworthy" again.
Allendale Pharmaceuticals said the Food and Drug Administration has approved U.S. sales of the sponge, which was the favorite nonprescription birth control product of women when it was withdrawn from the market in 1995.
"They can re-enter the U.S. market," FDA spokeswoman Susan Cruzan said. "The product was found to be safe and effective."
The polyurethane sponges, which have been sold in Canada and over the Internet since March 2003, will be available soon on a company Web site and later at retailers.
"I'm overwhelmed," Gene Detroyer, president and chief executive officer of Allendale Pharmaceuticals, told The Associated Press in an exclusive interview. "I am pleased both from a business point of view ... and from the point of view that we can add another contraceptive for women."
Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, American Home Products, which is now Wyeth of Madison. American Home stopped making the sponge rather than upgrade a manufacturing plant after FDA found deficiencies there.
The device's effectiveness and safety were never questioned.
The fierce loyalty of the product's fans was depicted in hilarious fashion on the sitcom "Seinfeld." The character Elaine Benes scoured stores for her favorite birth control, then stretched her supply by setting "spongeworthy" standards for prospective lovers.
The Today Sponge prevents pregnancy by covering the cervix and releasing spermicide from inside the soft, concave device. Roughly 250 million of the 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 availability.
Allendale Pharmaceuticals said the Food and Drug Administration has approved U.S. sales of the sponge, which was the favorite nonprescription birth control product of women when it was withdrawn from the market in 1995.
"They can re-enter the U.S. market," FDA spokeswoman Susan Cruzan said. "The product was found to be safe and effective."
The polyurethane sponges, which have been sold in Canada and over the Internet since March 2003, will be available soon on a company Web site and later at retailers.
"I'm overwhelmed," Gene Detroyer, president and chief executive officer of Allendale Pharmaceuticals, told The Associated Press in an exclusive interview. "I am pleased both from a business point of view ... and from the point of view that we can add another contraceptive for women."
Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, American Home Products, which is now Wyeth of Madison. American Home stopped making the sponge rather than upgrade a manufacturing plant after FDA found deficiencies there.
The device's effectiveness and safety were never questioned.
The fierce loyalty of the product's fans was depicted in hilarious fashion on the sitcom "Seinfeld." The character Elaine Benes scoured stores for her favorite birth control, then stretched her supply by setting "spongeworthy" standards for prospective lovers.
The Today Sponge prevents pregnancy by covering the cervix and releasing spermicide from inside the soft, concave device. Roughly 250 million of the 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 availability.
That is GREAT news!!!
