Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
Wockhardt said it is launching the product immediately in the US market.
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.
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.
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.
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
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.
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.
Donald Trump's Presidency of the United States will open new opportunities for India though certain sectors, especially pharma and IT, may face the heat if the incoming president decides to impose restrictions on imports and H1B visa regulations, experts said on Wednesday. Prime Minister Narendra Modi's friendly relationship with Trump will have a positive bearing on Indo-US relations but India may have to adapt its strategies to maintain cooperation in areas of mutual interest.
US President-elect Donald Trump has nominated Indian-American scientist Jay Bhattacharya to lead the National Institutes of Health (NIH), the country's top health research and funding institutions. Bhattacharya, a professor of Health Policy at Stanford University, is known for his research on the health and well-being of vulnerable populations. Trump also nominated Jim O'Neill as the deputy secretary of Health and Human Services to work alongside Robert F. Kennedy Jr.
The TIME 100 AI list is an interesting assortment of titans. Indians make up about 20 per cent of the coveted list, which is pretty commendable, notes Sandeep Goyal.
The United Kingdom extracted USD 64.82 trillion from India over a century of colonialism between 1765 and 1900 and USD 33.8 trillion of this went to the richest 10 per cent -- enough money to carpet London in notes of 50 British pound almost four times over.
Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.
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.
The tailwind of low price erosion in the US generics market, seen by domestic pharmaceutical companies in calendar year 2023 (CY23), may be reversing slowly, caution analysts. According to the latest data from US-based Centers for Medicare and Medicaid Services (CMMS), price erosion in calendar year 2024 (CY24) on a year-to-date (YTD) basis stood at a high of 15 per cent in the oral solid dosage (OSD) segment compared to a low of 1 per cent in CY23. This erosion, according to a report by Antique Stock Broking, was the highest in the last three years.
In his second term in office, UP Chief Minister Yogi Adityanath has retained 34 portfolios.
The US subsidiary of Sun Pharmaceuticals, Caraco Pharmaceutical Laboratories, has received a warning letter from the Food and Drug Administration.
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.
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.
The controversy has sparked reactions across states. The famous Mankameshwar temple in Uttar Pradesh has now banned offerings of 'prasad' bought by devotees from outside and said they can offer homemade 'prasad' or fruits.
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.
With 62 filings, domestic pharma companies have filed the maximum number of drug master filings with the US Food and Drug Administration in the July-September 2006 quarter.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
The Jammu and Kashmir administration on Saturday sacked six government employees, including five policemen, for their 'deep involvement in anti-national activities', officials said.
'Someone posts a job on LinkedIn and there are a thousand resumes in an hour? This is not the America IT professionals are used to.' 'Once they lose their job, it's impossible to get a job.'
The identification of host dependency factors mediating virus infection may provide key insights into effective molecular targets for developing broadly acting antiviral therapeutics against SARS-CoV-2 and other deadly coronavirus strains, according to the researchers.
The US-based Dawn Alliance group is planning to set up a United States Food and Drug Administration-approved generic drug manufacturing facility in India.
India's pharmaceutical exports to Iran have been hit owing to depleting rupee reserves in the West Asian country because of India stopping the import of crude oil from it in 2019 following US sanctions. Pharmaceutical exports dropped 71.25 per cent in April-August this year over the same period last year. The data from the Pharmaceutical Exports Promotion Council (Pharmexcil) showed exports to Iran had declined 31.29 per cent in 2022-23 as against the previous financial year.
President-elect Donald Trump announced a slate of key Cabinet nominations, including tapping former Democratic presidential candidate Robert F. Kennedy Jr. as his Secretary of Health and Human Services and former Congressman Doug Collins of Georgia as Secretary for Veterans Affairs. Trump also named Jay Clayton as US Attorney for the Southern District of New York, Todd Blanche as Deputy Attorney General, and Dean John Sauer as Solicitor General of the United States.
Two United States senators have asked the US Food and Drug Administration (USFDA) to provide details of market approvals given to all medicines sold by India's largest drug-maker Ranbaxy in that country.
This increase is despite the decreased growth of drug sales in the US - the world's largest market - which has seen a tightening of regulations and aggressive competition.
However, official sources said the Assam Rifles -- a border guarding force -- primary mandate or task is not drug law enforcement.
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