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Somatuline Depot Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for patent extension for Tercicas Somatuline Depot.

Advisors Say Embeda Abuse Plan Could Help

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FDA advisors say that Alpharma abuse-prevention plans for Embeda could deter some, but not all, potential abusers.

FDA OKs Eisai NDA for Seizure Drug

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FDA approves an Eisai Corp. NDA for Banzel (rufinamide), indicated as adjunctive treatment of seizures associated with Lennox-Gast...

Altus Plans on 2009 NDA for Trizytek

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Altus Pharmaceuticals says it plans to submit an NDA for Trizytek (liprotamase) during the first-half of 2009.

FDA Reports Continuing Shortage with Zostavax

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FDA reports that Merck continues to experience shipping delays for Zostavax (zoster vaccine live).

Panel Backs Remoxy Approval

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FDA advisors recommend approval of Pain Therapeutics Remoxy with labeling that describes it as tamper-resistant rather than abuse-...

Advisor Input Sought on Dermal Fillers

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FDA asks an advisory panel to consider the safety and evaluation of potential new indications for dermal filler devices.

Pediatric Advisory Panel to Meet

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Federal Register Notice: FDAs Pediatric Advisory Committee will meet 12/9 to discuss an IRB referral of a clinical investigation o...

Ethics Panel to Discuss Child Stem Cell Transplants

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Federal Register Notice: FDAs Pediatric Ethics Subcommittee will discuss a clinical investigation of granulocyte colony stimulatin...

FDA Seeks Injunction Against Generic Maker Actavis

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FDA seeks a permanent injunction against Actavis Totowa over continuing compliance issues involving drug products made at its faci...