STORY FROM: Drugs & Medical Devices

Teva Properly Provided Amiodarone Medication Guides to Pharmacy, Texas Federal Judge Rules

AUSTIN, Texas — A Texas federal judge has awarded a generic drug maker summary judgment in an amiodarone death case, ruling that it properly provided the dispensing pharmacy with Medication Guides for the drug and was not required to provide them to the patient.

Senior Judge Alan Ezra of the U.S. District Court for the Western District of Texas explained that nothing in 21 C.F.R. § 208.24 required Teva Pharmaceuticals USA Inc. to provide its Medication Guide for generic Cordarone directly to the patient.

Klaus Glaser developed pulmonary fibrosis and pulmonary toxicity allegedly as a result of his ingestion ...

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