Medicis Asks Fda To Stay Solodyn Anda Approvals

Elizabeth Jones

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Medicis Asks Fda To Stay Solodyn Anda Approvals

机译：Medicis要求Fda保持Solodyn Anda的批准

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Medicis Pharmaceutical has filed a citizen petition asking the FDA to grant a 30-month stay of approval on certain AND As for its acne drug Solodyn.rnSandoz, Mylan and Barr, which has been bought by Teva Pharmaceutical Industries, want to make generic versions of Solodyn (minocy-cline HCl) and have filed separate AND As with Paragraph IV certifications. Medicis has sued each drugmaker and maintains it is entitled to the 30-month stay.

机译：Medicis Pharmaceutical已提交公民请愿书，要求FDA批准某些AND的批准搁置30个月。至于其痤疮药物Solodyn.rnSandoz，Mylan和Barr（已被Teva Pharmaceutical Industries购买）希望制造仿制药。 Solodyn（盐酸氨氯西林）并已单独提交了AND条款IV认证。 Medicis起诉了每个制药商，并维持其有权享有30个月的逗留期。

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《Washington Drug Letter》 |2009年第9期|9|共1页
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Elizabeth Jones;
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Medicis Asks Fda To Stay Solodyn Anda Approvals

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