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FDA OKs Lannett ANDA for Generic Dilaudid

[ Price : $8.95]

FDA approves a Lannett ANDA for a generic copy of Purdue Pharmaceuticals' Dilaudid tablets.

Mylan ANDA for Generic Keppra 1,000 mg Approved

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FDA approves a Mylan ANDA for levetiracetam tablets 1,000 mg, a generic copy of UCB Pharmas antiepileptic Keppra.

CGMPs Guidance on PET Drugs

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Federal Register Notice: FDA releases a guidance, PET Drugs Current Good Manufacturing Practice.

Participants Sought for CVM Electronic Data Pilot

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Federal Register Notice: FDAs Center for Veterinary Medicine seeks sponsors to participate in a pilot project to test the electron...

FDAers Earning $200K-plus Double in 2 Years

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Our latest FDA salary survey from 2008 agency data obtained under FOIA shows that the agency has doubled in two years the number o...

Abbott sNDA for New Simcor Dosages

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Abbott submits a supplemental NDA for two new dosage strengths (500/40 mg and 1,000/40 mg) of Simcor, its cholesterol-lowering fix...

Bayer Recalls 1 Lot of Alka-Seltzer Gels

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FDA says that Bayer Consumer Care is recalling one lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Li...

Salix Says Rifaximin NDA on Target for 2010

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Salix says it plans to submit an NDA for rifaximin for treating non-constipation irritable bowel syndrome in the first half of 201...

Stryker Recalls Surgical Navigation Systems

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CDRH posts a notice of a 10/26 Stryker recall of its Operating Room System II Surgical Navigation System.

Young Adults Taking More Rx Meds

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The Agency for Healthcare Research and Quality says the prescription drugs accounted for a higher share of medical expenses for th...