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Oct. 8, 2012

Vol. 9 No. 197

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Apotex Lawsuit: FDA Wrongly Holding Up ANDA Approvals Because of Lost Inspection Report

Apotex is taking the FDA to court for failing to grant timely approval of its ANDAs for two Sanofi hypertension treatments, Avapro and Avalide. Read More

Amphastar Slow to Report SAEs, Form 483 States

Amphastar Pharmaceuticals is slow to notify the FDA about complaints of serious and/or unexpected adverse events associated with its various generic drug products, a Form 483 states. Read More

Coming Combo Products Guidance to Reflect Rapid Technology Changes

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Sept. 20. Read More

Johnson & Johnson Agrees to Settle Five Rispersal Suits

Johnson & Johnson agreed to settle five lawsuits over claims that its antipsychotic drug Risperdal caused increased breast-tissue growth in boys. Read More

FDA Agrees Generic Wellbutrin XL Is Not Equivalent and Is Pulled Off Market

FDA admits mistake with a generic drug, but it took too long, says Many lessons for consumers, doctors and pharmacists about generic drugs can be learned. Read More

Pfizer: Prevnar 13 Effective in Young Adults

The 13-valent pneumococcal polysaccharide conjugate vaccine (Prevnar 13) elicits as strong an immune response in adults 18 to 49 as it does in those ages 60 to 64, according to Phase III results reported by Pfizer, the vaccine’s maker. Read More

Medication Tied to Rare Meningitis Outbreak Reached 23 States

A steroid medication linked to the death of at least five people from rare fungal meningitis may have been administered to patients in 23 states, the U.S. Centers for Disease Control said, raising fears the rare outbreak could spread. Read More

BioSante Pharmaceuticals Merges With ANI Pharm in $95 Million Deal

A Minnesota pharmaceutical company is merging with another drug company from Illinois in a deal that is valued at $95 million. Read More

Japanese Company Buys Montana Pharmaceutical Company

A Japanese pharmaceutical company is acquiring Bozeman-based LigoCyte Pharmaceuticals in a $60 million deal to expand its vaccine division, Takeda Pharmaceutical said. Read More