Natco Pharma's anti-cancer drug, NRC-AN-019, has received 'Orphan Drug' designation from the US Food and Drug Administration (USFDA) for three indications - glioma (brain tumour), pancreatic cancer and chronic myelogenous leukemia.
Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
Regulator says fee would enable it to quicken approval process.
Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.
Ranbaxy Laboratories Ltd said on Thursday that it has bagged the US Food and Drug Administration's approval for manufacturing and marketing Loratadine and Pseudoephedrine Sulfate Extended-release tablets.
Alarmed by the growing number of advertisements on 'miracle' drugs being shown on television channels, Maharashtra Food and Drug Administration
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
In the final part of a three-part series on America's war on substandard Indian generic drugs, Aziz Haniffa speaks about American doctors' contempt for drugs exported from India and the ineptitude of the US Food and Drug Administration to stop the menace.
Some US doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.
The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.
China has formally apologised to Nigeria for alleged export of fake drugs including some labelled as 'Made in India' by some Chinese firms to the country and assured to take punitive action against those involved in the scandal.
In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.
In his second term in office, UP Chief Minister Yogi Adityanath has retained 34 portfolios.
The Maharashtra Food and Drugs Administration has initiated action against manufacturers of medicines and instruments, newspapers, TV channels and cable operators making outrageous claims through advertisements.
Wockhardt said it is launching the product immediately in the US market.
It is now probing the quality of AIDS medicines supplied by the company to developing countries under US government-funded programmes. Estimates suggest that Ranbaxy has received over $9 million from the programme so far. Ranbaxy had a turnover of $1.5 billion in 2007-08, of which a quarter came from US sales.
Pharma major Wockhardt on Wednesday said it has launched Tamsulosin capsules, indicated for problem of prostate enlargement, in the US market on the day one of the expiry of patent covering the drug.
This move could cost $299 million a year for Indian pharma players.
Cipla has got tentative approval from the USFDA for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.
India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.
Drug-maker Ranbaxy Laboratories on Thursday said it has received the US health regulator's approval to market Quinapril Hydrochloride and Hydrochlorothiazide tablets, used in treatment of high blood pressure, in different strengths in America.
Import alert on unit-6 facility might be lifted by FDA by Sept.
A new report says laws crimp Medicare's ability to control costs on cancer, leading to a 267% increase in drug spending over seven years
For the first time, a once-a-day pill which reduces the chance of contracting HIV among high risk groups "significantly" has got green signal in the United States, where 1.2 million people are infected by the deadly disease.
Drug maker Sun Pharmaceutical Industries on Thursday said it has received the US health regulator's nod for marketing a generic version of the Keppra injection, used for treating epilepsy, in the American market.
Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration for marketing the cardiac drug.
Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.
Indian drugmaker Morepen Laboratories Ltd has filed an international patent for the manufacturing process of Desloratadine, the Bombay Stock Exchange said on Wednesday.
A tiny dead snake was allegedly found in a packet distributed under the mid-day meal scheme meant for children aged between six months and three years at an anganwadi or a government-run nursery school in western Maharashtra's Sangli district, prompting the authorities to launch a probe.
The US subsidiary of Sun Pharmaceuticals, Caraco Pharmaceutical Laboratories, has received a warning letter from the Food and Drug Administration.
Ranbaxy Laboratories on Friday said it had received approval from US Food and Drug Administration to manufacture and market nitrofurantoin monohydrate macrocrystals capsules (100 mg) and planned to bring the new drug to the market in April.
There are also lingering concerns over the culture of misuse of pharmaceutical products in India, which has, in the past, led to other drugs becoming increasingly ineffective.
The firm, however, said the anti-cholesterol tablets meant for the US market will be produced at its Mohali SEZ plant in Punjab and not at the three units banned by the US health regulator.
Through a Freedom of Information Act request, the Show '20/20' obtained lists of recent health violation records from the FDA, the agency in charge of inspecting airlines and their outside food caterers.
The United States Food and Drug Administration has given tentative approval to the fixed-dose combination drug products lamivudine and zidovudine tablets -- manufactured by Aurobindo Pharma Ltd.
To be called Central Drug Administration or National Drug Authority, it will have 10 sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, etc.
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