| According to Spain, the reason for using a soft loan is simply that they thought it would be more easily approvable by the Commission. |
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| Such opinion will also list any variations which are not considered approvable. |
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| The Company submitted its response to the second approvable letter last September and this response has been acknowledged as complete by the FDA, allowing for the Class 2 review. |
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| The approvable letter also states that additional submissions, filed by Neurochem as part of its response to this approvable letter, may address issues raised in this letter. |
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| In September, the FDA granted us an Approvable Letter for our once-daily formulation of tramadol, indicating that our formulation is approvable for the U. S. market subject to the resolution of certain matters. |
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| In November 2006, the FDA advised Neurochem that the response submitted in October was complete, as it responded to all of the items raised in the August approvable letter. |
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| In the United States, on September 28, 2006, we received an approvable letter from the FDA indicating that our once-daily formulation of tramadol is approvable, subject to the resolution of certain issues. |
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| To reduce the overall consumption of approvable substances and products, the Minister for the Environment can lay down rules restricting or banning the use of such substances and products in specific areas of land. |
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| In addition, the number of approvable letters, which state what conditions must be met for a drug to be approved increased. |
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| Food and Drug Administration has issued an approvable letter for Once-A-Day LUVOX CR Extended-Release Capsules, for which Jazz Pharmaceuticals and Solvay Pharmaceuticals, Inc. |
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| Pramlintide acetate as adjunctive therapy for insulin-treated diabetes was considered to not be approvable at this time by a Food and Drug Administration advisory panel. |
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| This decision follows a number of meetings with the FDA since October 2004, when the Company received an Approvable Letter from the FDA for Riquent. |
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