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Amneal, Aided by FTC, Succeeds in Getting Teva Patents Removed from Orange Book

Amneal, Aided by FTC, Succeeds in Getting Teva Patents Removed from Orange Book
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New Drug Application (NDA) Submissions 505(b)(1) Or 505(b)(2)

There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough.

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Federal Circuit Affirms ANDA Approval Restrictions

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. reviews findings regarding patent obviousness and infringement in Hatch Waxman litigation.

Norwich pharmaceuticals incSalix pharmaceuticals ltdJohn deere coSalix pharmaceuticalsFederal circuitAbbreviated new drug applicationOrange book listedKansas city

Axsome Reaches Patent Settlement Over Sunosi With Unichem

Axsome Therapeutics Inc has reached a settlement with Unichem Laboratories Ltd over patent litigation concerning Axsome's product Sunosi.

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Alembic Pharma gains 0 92% on USFDA nod for Sacubitril and Valsartan tablets

Alembic Pharma gains 0 92% on USFDA nod for Sacubitril and Valsartan tablets
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Us food drug administrationAlembic pharmaceuticals ltdDrug administrationAbbreviated new drug application