Today sponge in Canada: U.S. debut is nearing
While minor hurdles have delayed the projected 1999 launch, officials with Allendale (NJ) Pharmaceutical say the company is nearing the U.S. reintroduction of the Today vaginal contraceptive sponge. Shipment of the product to Canada should be in place by Contraceptive Technology Update’s press time, where approvals have been completed, says Gene Detroyer, company president and CEO.
"Now with most everything out of the way, it will be in the hands of the FDA [Food and Drug Administration]," Detroyer says of the American product launch. "I anticipate the sponge being available in the U.S. from e-tailers [firms that sell products directly through the Internet] the moment the FDA gives us the green light."
Allendale Pharmaceuticals purchased rights to Today from Ameri can Home Products of Madison, NJ, in early 1999. The sponge was withdrawn from the market in 1995 when its formers owners determined it was too costly to correct manufacturing problems at the old factory where it was made. Since its New Drug Application with the FDA remained current, the company did not have to conduct studies to demonstrate the sponge’s safety and efficacy. It has submitted several product samples to the regulatory agency to make sure the current sponge is similar in formulation to the ori gin- al. (CTU reported on Allendale Pharmaceutical’s acquisition in May 1999; see p. 49 of that issue.)
The company’s Web site, www.todaysponge. com, carries updates on the sponge’s status and a clinical summary. After FDA approval, women will be able to order the sponge on-line at www. birthcontrol.com, with retail sales soon to follow.
[For more details about the Today sponge, contact Allendale Pharmaceutical, 73 Franklin Turnpike, Allendale, NJ 07401. Telephone: (201) 934-4499. Fax: (201) 327-0035. Alternate Web: www.allendalepharm. com. E-mail: [email protected].]
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