Dec 23 (Reuters) - Alimera Sciences Inc:
* Says received complete response letter from FDA regarding its new drug
application for Iluvien
* Says FDA issued CRL to communicate its decision that the NDA cannot be
approved in its present form
* Says no new clinical studies were requested in the CRL
* Says FDA asked for analyses of the safety and efficacy data through month 36
of the fame study
* FDA is also seeking more data regarding manufacturing, packaging and
sterilization of Iluvien
* FDA asked exploratory analyses in addition previously submitted data, to
further assess benefits, risks of iluvien
* FDA also indicated that it had observed deficiencies in manufacturing
practices of 2 of co's 3-party manufacturers
* Says third-party manufacturers are in the process of resolving these
deficiencies
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* Says received complete response letter from FDA regarding its new drug
application for Iluvien
* Says FDA issued CRL to communicate its decision that the NDA cannot be
approved in its present form
* Says no new clinical studies were requested in the CRL
* Says FDA asked for analyses of the safety and efficacy data through month 36
of the fame study
* FDA is also seeking more data regarding manufacturing, packaging and
sterilization of Iluvien
* FDA asked exploratory analyses in addition previously submitted data, to
further assess benefits, risks of iluvien
* FDA also indicated that it had observed deficiencies in manufacturing
practices of 2 of co's 3-party manufacturers
* Says third-party manufacturers are in the process of resolving these
deficiencies
((Bangalore Equities Newsroom; +91 80 4135 5800; within U.S. +1 646 223 8780)) (For more news, please click here) 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.