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FDA Hits Lilly on Web Page Colored Images

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An FDA untitled letter to Eli Lilly cites the companys use of a promotional Web page for brain imaging drug Amyvid because it incl...

Janssen Resubmits Xarelto sNDAs to Address FDA Questions

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Janssen Research & Development refiles two supplemental NDAs for Xarelto following information requested by FDA in a 6/21 complete...

Celgene PLans NDA for Psoriatic Arthritis

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Celgene International plans to file an NDA early in 2013 for apremilast, indicated for treating patients with psoriatic arthritis.

FDA Clears Soligenix IND to Test Crohns Disease Therapy

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FDA clears a Soligenix IND to begin Phase 1/2 studies of SGX203 for induction treatment of pediatric Crohns disease.

Impax and Genzyme Settle Renvela Patent Litigation

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Impax says it has an agreement with Genzyme under which it will be licensed to produce generic forms of Renvela and Renagel in 201...

FDA Holds Fast to Voluntary Strategy on Animal Antibiotics

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Amid rising criticism, FDA holds fast to its previously announced voluntary compliance approach to the use of human-use antibiotic...

FDA Extends Review on Salix Crofelemer NDA

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FDA says it is extending past the 9/5 PDUFA deadline its review of a Salix NDA for crofelemer.

High Court Likely to Review Hatch-Waxman Safe Harbor Conflict: Attorney

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Fenwick & West attorney Michael Shuster sees the U.S. Supreme Court reviewing two conflicting federal circuit cases (Classen and M...

Endo Asks FDA Support for Crush-resistant Opana ER

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Endo asks FDA to take steps to promote use of crush-resistant pain management drugs such as its Opana ER.

Perrigo Files ANDA for Generic ProAir

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Perrigo says it has filed an ANDA for albuterol sulfate HFA inhalation aerosol, a generic copy of Tevas ProAir HFA.