Teva Will Inherit OAI Status Of Andrx' Oral Contraceptives
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA will continue to block approval of Andrx' oral contraceptives until manufacturing issues are resolved despite the company's intention to transfer its pending ANDAs to Teva
You may also be interested in...
Watson boosts generics portfolio from Teva/Barr
Watson will acquire a portfolio of generics being divested as part of the Teva/Barr deal, pending its consummation, for an upfront purchase price of $36 million. The portfolio includes 15 FDA-approved products, notably cyclosporine capsules and liquid; desmopressin tablets; glipizide/metformin tablets; mirtazapine orally disintegrating tablets; and metoclopramide tablets - as well as two in development. Under the terms of the agreement, Watson will make additional payments to Teva as development-stage products progress and obtain the products under a manufacturing and supply agreement from Teva until manufacturing is transferred. The deal does not appear to contain any oral contraceptives, which are among the most coveted assets that Teva and Barr could have to divest (1"The Pink Sheet," Aug. 25, 2008, p. 21). While it remains unclear whether the merger firm will have to pare down its portfolio of OCs, it's unlikely that any would go to Watson, which spun off some of those products to Teva as part of its 2006 acquisition of Andrx (2"The Pink Sheet" DAILY, May 5, 2006)
Watson boosts generics portfolio from Teva/Barr
Watson will acquire a portfolio of generics being divested as part of the Teva/Barr deal, pending its consummation, for an upfront purchase price of $36 million. The portfolio includes 15 FDA-approved products, notably cyclosporine capsules and liquid; desmopressin tablets; glipizide/metformin tablets; mirtazapine orally disintegrating tablets; and metoclopramide tablets - as well as two in development. Under the terms of the agreement, Watson will make additional payments to Teva as development-stage products progress and obtain the products under a manufacturing and supply agreement from Teva until manufacturing is transferred. The deal does not appear to contain any oral contraceptives, which are among the most coveted assets that Teva and Barr could have to divest (1"The Pink Sheet," Aug. 25, 2008, p. 21). While it remains unclear whether the merger firm will have to pare down its portfolio of OCs, it's unlikely that any would go to Watson, which spun off some of those products to Teva as part of its 2006 acquisition of Andrx (2"The Pink Sheet" DAILY, May 5, 2006)
Watson-Andrx Merger Deadline Extended
The closing date for the Watson-Andrx merger is being extended from Sept. 12 to Nov. 13 to allow for "additional time to confer with the FTC," the companies announced July 10