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FDA OKs Norbrooks Labs sANADA for Bovine Parasites

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Federal Register Final rule: FDA approves a Norbrook Laboratories supplemental ANADA for claims of effectiveness against parasites...

DDMAC Cites Scios Reminder Material for Natrecor

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DDMAC cites Scios over imagery in drug reminder materials promoting Natrecor.

FDA Withdraws Multiple NDAs, ANDAs

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Federal Register Notice: FDA withdraws approval of 73 NDAs and 62 ANDAs that are no longer marketed.

FDA OKs Abilify for Adolescent Schizophrenia

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FDA approves an Otsuka Pharmaceutical supplemental NDA for atypical antipsychotic Abilify (aripiprazole) for treating schizophreni...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Biotivia America, Cytosol Laboratories, EXACT Sciences, Efficas, Health MarketPl...

Panel to Discuss Abbot Vascular and Thoratec PMAs

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 11/29-30 to discuss Abbott Vasculars Xience V Everolimus ...

Import Plan to Rely on Product Certifications

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A new Bush administration import safety plan recommends giving FDA the authority to require a certification from foreign governmen...

FDA OKs Elanco sNADA

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Federal Register Final rule: FDA approves an Elanco Animal Health sNADA for increased monensin in cattle feed containing ractopami...

FDA Rejects Sandoz ANDA for Generic Lovenox

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FDA sends Sandoz a not approvable letter on an ANDA for a generic copy of Sanofi-Aventis Lovenox (enoxaparin sodium) for injection...

Stop Work on Reagan-Udall: DeLauro

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Rep. Rosa DeLauro asks FDA to stop work on the Reagan-Udall Foundation and explain how it will not place too much industry influen...