* FDA says data in current filing insufficient: Co
* Co says FDA did not ask for safety data, more analysis
* Says has additional data responsive to FDA guidance
* Says amended suit against Lupin on acne drug Solodyn
July 6 (Reuters) - Medicis Pharmaceutical Corp said health regulators indicated in a letter last week that data in its current filing for marketing approval of its body sculpting device, LipoSonix, was not sufficient.
The specialty pharmaceutical company said, in a letter dated July, 1, the U.S. Food and Drug Administration has asked for additional data in a new filing for approval. In a regulatory filing, Medicis said it had the additional information that was 'responsive to the FDA's guidance' and noted that the health regulator had not asked for additional safety data or additional analysis of existing safety data.
LipoSonix, which would be Medicis's entry into the foray of devices, is a body sculpting device that focuses ultrasound energy on fat cells right under the skin in patients who have not responded to diet and exercise. Medicis had said it expects to launch the product in 2011. LipoSonix has already been approved and marketed in European countries like France, the United Kingdom, Spain and Germany.
On July 1, the company also added new claims in its patent infringement lawsuit against Indian firm Lupin Ltd on acne treatment Solodyn.
Medicis shares closed at $21.97 Tuesday on the New York Stock Exchange.
(Reporting by Vidya L Nathan in Bangalore; Editing by Jarshad Kakkrakandy) Keywords: MEDICISPHARMACEUTICALS/ (vidya.loganathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: vidya.loganathan.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* Co says FDA did not ask for safety data, more analysis
* Says has additional data responsive to FDA guidance
* Says amended suit against Lupin on acne drug Solodyn
July 6 (Reuters) - Medicis Pharmaceutical Corp said health regulators indicated in a letter last week that data in its current filing for marketing approval of its body sculpting device, LipoSonix, was not sufficient.
The specialty pharmaceutical company said, in a letter dated July, 1, the U.S. Food and Drug Administration has asked for additional data in a new filing for approval. In a regulatory filing, Medicis said it had the additional information that was 'responsive to the FDA's guidance' and noted that the health regulator had not asked for additional safety data or additional analysis of existing safety data.
LipoSonix, which would be Medicis's entry into the foray of devices, is a body sculpting device that focuses ultrasound energy on fat cells right under the skin in patients who have not responded to diet and exercise. Medicis had said it expects to launch the product in 2011. LipoSonix has already been approved and marketed in European countries like France, the United Kingdom, Spain and Germany.
On July 1, the company also added new claims in its patent infringement lawsuit against Indian firm Lupin Ltd on acne treatment Solodyn.
Medicis shares closed at $21.97 Tuesday on the New York Stock Exchange.
(Reporting by Vidya L Nathan in Bangalore; Editing by Jarshad Kakkrakandy) Keywords: MEDICISPHARMACEUTICALS/ (vidya.loganathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: vidya.loganathan.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.