Fwd: CDER New 8/21/2008

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DRUGS UPDATE SOME YOU MAY TAKENote: forwarded message attached. Jeanne

August 21, 2008

Drug Safety Oversight Board Meeting, July 17, 2008

FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). Drug Information

Guidance for Industry: Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment [PDF]

New and Generic Drug Approvals

Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision

Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision

Abilify (aripiprazole) Orally Disintegrating Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision

Abilify (aripiprazole) Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision

Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision

Geodon (ziprasidone mesylate) Intramuscular Injection, Pfizer, Inc., Labeling Revision

Invega (paliperidone) Extended-Release Tablets, & Pharmaceutical Research & Development, LLC, Labeling Revision

Navane (thiothixine) Capsules, Pfizer, Inc., Labeling Revision

Risperdal (risperidone) Oral Solution, & Pharmaceutical Research & Development, LLC, Labeling Revision

Risperdal (risperidone) Orally Disintegrating Tablets, & Pharmaceutical Research & Development, LLC, Labeling Revision

Risperdal (risperidone) Tablets, & Pharmaceutical Research & Development, LLC, Labeling Revision

Risperdal Consta (risperidone) Intramuscular Injection, & Pharmaceutical Research & Development, LLC, Labeling Revision

Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision

Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision

Symbyax (fluoxetine hydrochloride and olanzapine) Capsules, Eli Lilly and Co., Labeling Revision

Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Co., Labeling Revision

Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision

Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Labeling Revision

USP Chapter <467> Residual Solvents - Additional Information

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