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Issue dated - 07th Oct. 2004

Home > Regulatory

Patent clearance in 30 days: Centre
The Union government has started integrating its patent offices in four metro cities to clear applications within 30 days to 60 days from the date of filing, minister of state for commerce and industry E V K S Elangovan told Express Pharma Pulse.

ABLE urges govt for single window drug approval process
The Association of Biotechnology Led Enterprises (ABLE) has urged the government to create a single regulatory agency for bio-pharmaceutical products, said a press release.

Ranbaxy to recommend short term use of rofecoxib drug
Ranbaxy Laboratories Ltd will continue to market its arthritis drug Rofibax (rofecoxib) but would recommend a restricted use following the drug's innovator Merck's withdrawal of its US dollar 2.5 billion brand Vioxx voluntarily last week after a study showed "increased relative risk for cardiovascular events beginning after 18 months of treatment in patients taking the drug".

Roche chief visits India
The post patent era is attracting a host of global pharma majors eyeing a pie of the huge business opportunity in India. While Bristol Myers Squibb (BMS) and Merck & Co of the US have already announced their intentions of re-entering India, the global head of the pharmaceuticals of F Hoffmann-La Roche Limited (FHLR), William Burns visit in the first week of October aims to explore business opportunities in India.

DRL announces litigation on ANDA for Finasteride tabs
Dr Reddy’s Laboratories (DRL) has announced that the company had filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration for Finasteride tablets 1 mg with a Paragraph IV certification on three of the four Orange Book patents listed for the drug, in June 2002.

  
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