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Mylan Files ANDA for Generic Amrix

[ Price : $8.95]

Mylan files a Waxman-Hatch Paragraph 4-certified ANDA for a generic copy of Cephalon and Eurands skeletal muscle relaxant Amrix.

More Biologics Monitoring Needed: Study

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Researchers say that some classes of biologics should be monitored more closely because they are prone to more safety-related prob...

Lilly Prepared to Settle More Zyprexa Claims

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Lilly says it is in discussions that could lead to payment of $1.415 billion to resolve federal and state Medicaid claims over Zyp...

FDA Extends Review on Pfizer Osteoporosis NDA

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FDA extends by three months its review of a Pfizer NDA for the osteoporosis drug Fablyn.

CGMP Problems Found at Biosafe Laboratories

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FDAs Chicago District Office warns Biosafe Laboratories 16 cGMP violations in its manufacturing of several diagnostic tests.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites AliMed, Bayer HealthCare, Biosafe Laboratories, Dherbs.com, The Lifestyle GP Co....

Emergency Authorization Issued for Doxcycline Kits

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Federal Register Notice: FDA issues an Emergency Use Authorization for doxycycline hyclate tablet emergency kits for USPS workers ...

OMB OKs Dietary Ingredient Info

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Federal Register Notice: OMB approves FDAs collection of information on premarket notification for a new dietary ingredient.

Location Changes for ICH Prep Meeting

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Federal Register Notice: FDA amends the notice for the 10/21 preparation meeting for the ICH meetings in Brussels.

FDA Approves Tevas Generic Duragesic

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FDA approves Tevas ANDA for generic Duragesic in four strengths.