FDA

Ranbaxy reports Rs 2,983 crore loss in third quarter

Ranbaxy reports Rs 2,983 crore loss in third quarterIndian pharmaceutical major, Ranbaxy Laboratories Ltd has reported a loss of Rs 2,983 crore for the quarter till December 2011 despite having over $2 billion worth of sale in the financial year 2011.

The company’s profitability was affected by a $500 million provision that was made to sort out its regulatory issues with the US department of justice investigations. The company also lost earnings due to losses in the foreign exchange market.

US DOJ files consent decree on Ranbaxy

US DOJ files consent decree on RanbaxyThe US Department of Justice has filed a consent decree in the district court of Maryland for the Indian pharmaceutical major, Ranbaxy aiming to resolve the four-year long investigation by the US Food and Drug Administration (FDA).

The consent decree required the company to make fundamental changes to its plants in India and in the US for complying with the standards in the US. The US Justice Department filed the consent decree in court yesterday requiring the Indian firm to comply with US manufacturing standards and ensure integrity of data in its plants in India as well as the US.

Johnson & Johnson's must outline risks of birth control Patch

Johnson & Johnson's must outline risks of birth control PatchThe FDA's Advisory Committee for Reproductive Health Drugs and a drug safety committee said that the Johnson & Johnson should more clearly explain the risks of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch.

The panel voted 19-5 in favorer of allowing the sale of Ortho Evra patch to continue. They said that its benefits are more than potential blood clot risks. The panel recommended that the FDA should allow the patch to remain in the market as a contraceptive option.

FDA approves Ranbaxy’s generic version of Lipitor

FDA approves Ranbaxy’s generic version of LipitorIndia pharmaceutical major, Ranbaxy Laboratories Ltd has received the approval from the US Food and Drug Administration to launch the generic version of drug Lipitor in the US market.

Ranbaxy’s Lipitor to be Out in November

Ranbaxy’s Lipitor to be Out in NovemberIt has been reported that Ranbaxy Laboratories will soon be launching its cholesterol drug Lipitor. It is believed that the drug will be out by 30th November. Following the revelation of the new drug, its shares on the BSE rose by 4% today.

It has been informed that the Ranbaxy is yet to take Food and drug Administration’s approval before launching its Lipitor, which is a generic version of Lipitor. The drug is available in the US where it is sold annually for $7 billion.

US FDA get sued for failure over banning of packaging chemical

US FDA get sued for failure over banning of packaging chemicalObservers have noted that the U. S. Food and Drug Administration has been sued over its failure to act on a petition to ban a chemical used in food packaging.

The Milwaukee Journal Sentinel has reported that the lawsuit, filed on Tuesday by the Natural Resources Defense Council, says the FDA failed to act on the council's petition to ban bisphenol A, a chemical used to line the cans of most food products.

The newspaper also said that the advocacy group submitted the petition in 2008. By law, the FDA had 90 days to respond to the petition.

FDA Turns Down Aridol Causing Pharmaxis Shares to Fall

FDA Turns Down Aridol Causing Pharmaxis Shares to FallThe rejection of a Pharmaxis's new drug application for an asthma diagnosis product, Aridol, by the US Food and Drug Administration (FDA) had resulted in a severe decline of 6%this morning.

Shares of the Sydney-based biotechnology company have more than doubled this year, surpassing the 30 percent increase for the benchmark S&P/ASX 200 index.

However, the FDA's pulmonary-allergy drugs advisory committee voted to recommend approval for the drug in November and Aridol is approved for sale in Australia, Korea and major European countries.

GAO report: FDA lacks expertise for estimating its own budget needs

fdaAccording to a Monday report released by the US government watchdog, the Government Accountability Office (GAO), the Food and Drug Administration (FDA) lacks the expertise required for estimating its own budget needs.

With the FDA struggling to execute its regulatory duties, several lawmakers and consumer advocates have been long complaining about the agency's lacks the staff and equipment. However, the recent GAO report has also brought to light the fact that FDA does not even have "the data to develop a complete and reliable estimate of the resources it needs."

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