• Pfizer Sues Dr Reddy Over Lipitor  in India

American pharma giant – Pfizer Inc., has taken Indian generic maker – Dr. Reddy – to court in an attempt to stop the sale of a generic version of Lipitor marketed by Dr Reddy. Lipitor has been one of the most successful blockbuster products for Pfizer with peak global sales at about US$14 billion; but this drug is about to lose in patent protection in the coming years. Indian patent for Lipitor is slated to expire in 2017.

 

 

• US FDA Issued Warning Letter to Ranbaxy Subsidiary

India-based generic maker, Ranbaxy, has agained faced compliance issue with US FDA with the company's liquid manufacturing facility located in Gloversville, New York. Ohm Laboratories, a wholly-owed subsidiary of Ranbaxy Laboratories, has received a warning letter from the FDA for its liquid manufacturing facility located in Gloversville, New York. The letter mentions certain cGMP violations based on site inspections conducted between July & August, 2009. The company is expected to continue to co-operate with the FDA to bring the matter to closure in a timely manner. 

 

 

• Pfizer’s Lyrica Faced Glitch for Expanded Indication

Pfizer’s New Drug Application (NDA) to expand Lyrica (pregabalin capsule) indication for the treatment of generalised anxiety disorder (GAD) has not been approved by FDA in their complete response letter. The application was a resubmission in response to a not-approvable letter issued by the FDA in August 2004. The FDA continues to review a separate application for Lyrica as adjunctive therapy for the treatment of GAD. Lyrica is used to control seizures & to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) or herpes zoster (post-herpetic neuralgia). Expressing his disappointment, Pfizer’s VP of Medical Affairs  - Steve Romano – said Pfizer will work with FDA to determine next steps. 

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