Inamed Gains FDA Nod
The Food and Drug Administration has overruled an advisory committee by granting conditional approval to Inamed (IMDC) to sell silicone gel breast implants for cosmetic surgery.
If the agency ultimately approves the Inamed product, the Santa Barbara, Calif.-based company will join Mentor (MNT), its next-door neighbor and rival, in selling these implants.
Mentor received conditional FDA approval in late July, but neither the company nor the FDA described the conditions or the timetable for meeting the conditions.
U.S. sales of silicone gel implants have been restricted since 1992 to a few uses, such as for women undergoing breast reconstruction after mastectomies and women whose silicone gel implants had ruptured. The restrictions reflect tougher FDA requirements that manufacturers provide long-term safety data to support applications for their devices.The FDA's announcement on Wednesday sent Inamed's stock rising $5.96, or 8.4%, to $77.02, a new 52-week high. In the first two hours of trading, more than 3.44 million shares were traded, or nine times the average daily trade for the last three months. Mentor's stock fell $2.38, or 4.5%, to $50.18 in heavy trading. The FDA offered no details about the conditions or timetable for approving Inamed's implant. "The conditions outlined in this letter are generally in line with our expectations and the discussions that took place at [previous] FDA advisory panel meetings, and we look forward to working with the agency ... in addressing them," said Nick Teti, Inamed's chief executive officer. The FDA noted that an advisory committee voted 5-4 in April against Inamed's silicone gel implant application. "Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel," the agency said Wednesday. The FDA said Inamed will no longer make a certain implant that had raised safety concerns among panel members.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV