FDA Alerts

August 24, 2009

Orlistat (Marketed as Alli and Xenical) Safety Review

FDA’s Early Communication about the Ongoing Safety Review of Orlistat. FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. […]
November 11, 2008

FDA Dilantin Investigation

Agency Investigating Dilantin Risks of SJS and TEN FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson […]
March 24, 2006

FDA Statement On Tysabri Review Time

Biogen Idec and Elan announced on March 22, 2006, that the Food and Drug Administration (FDA) had extended the regulatory review period for the reintroduction of […]
February 15, 2006

Tysabri Q&A Regarding Lifting of the Clinical Hold

Why is FDA lifting the clinical hold? We received detailed information on the extensive re-examination that Biogen and Elan undertook on all patients who had received […]
December 8, 2005

Paxil Birth Defect Lawsuit

The FDA (Food and Drug Administration) issued a Public Health Advisory in December of 2005 that warned doctors and patients of the potential for Paxil (paroxetine) […]
March 1, 2005

Tysabri (natalizumab) Questions and Answers

What is Tysabri? Tysabri is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, […]
November 23, 2004

Tysabri Approved by the FDA for Multiple Sclerosis

First Monoclonal Antibody Treatment For Multiple Sclerosis Approved FDA today licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis (MS) to […]
November 23, 2004

Questions and Answers on Natalizumab

What is natalizumab? Natalizumab is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, […]
November 23, 2004

Questions and Answers on Tysabri

What is Tysabri? Tysabri is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, […]