Fda

  • FDA approves weight-loss drug Contrave 5 days ago

    Washington: US regulators are greenlighting a new weight-loss drug called Contrave, the third in a string of approvals for anti-obesity treatments. The drug was developed by Orexigen Therapeutics Inc, based in La Jolla, California. The Food and Drug Administration said on Thursday that it is approved for use by people...
  • US 'not targeting' India companies: FDA February 22, 2014

    The United States is "not targeting" Indian companies, but has a strict quality control regime for all products being imported into America, the head of the US Food and Drug Administration said on Saturday. "We are not targeting Indian companies. We are undertaking our required regulatory activities. We inspect and take...
  • FDA prohibits Ranbaxy products in US January 24, 2014

    In a setback to Indian pharmaceutical giant Ranbaxy, the US has prohibited it from producing and distributing "substandard quality" drugs for the American market from its Toansa facility in Punjab. In an order, the Food and Drug Administration on Thursday prohibited Ranbaxy from distributing in the US the drugs manufactured using...
  • Maharashtra chemists on three-day strike from Today December 16, 2013

    Mumbai: Chemists in Maharashtra are observing a three-day shut down from Monday against the "draconian" interpretation of the Drug & Cosmetics Act, 1940 by the Maharashtra Food & Drug Administration (FDA). Chemists' associations will protest the FDA's crackdown on chemists operating without qualified pharmacists. There are around 55,000 chemists in Maharashtra...
  • US: What's changing, what's not, in a shutdown October 1, 2013

    Campers in national parks are to pull up stakes and leave, some veterans waiting to have disability benefits approved will have to cool their heels even longer, many routine food inspections will be suspended and panda-cams will go dark at the shuttered National Zoo. Those are among the immediate effects if...
  • US FDA bans imports from Ranbaxy's Mohali plant September 16, 2013

    Mumbai: The US Food and Drug Administration has issued an import alert against drugs manufactured at Ranbaxy's Mohali plant in Punjab over quality concerns. This means Ranbaxy will not be able to ship drugs manufactured at the plant to the US until the ban is lifted. This is the third...
  • Chemists shave their heads to protest against FDA rules June 26, 2013

    Sangli: Nearly 325 chemists from the district shaved their heads to protest the stringent implementation of rules by the FDA. The chemists in Sangli on Tuesday got their heads tonsured and the protest will continue with more chemists to follow the same, Maharashtra Chemists and Druggists Association president (west zone)...
  • Ranbaxy case: Should Indian patients worry over sub-standard drugs? June 5, 2013

    Mumbai: India exports drugs worth more than 15 billion dollars every year, a majority of which are US-bound. Questions are being raised about the standards and quality, after Ranbaxy's whopping 500 million dollar settlement with the US government. The generic drugs in question were manufactured at Ranbaxy's plants in Paonta...
  • US: Ranbaxy shares down on $ 500 mn fine May 14, 2013

    Mumbai: Ranbaxy Laboratories Ltd shares were down over 1 per cent in early trade on Tuesday after the generic drugmaker pleaded guilty to US felony charges related to drug safety and will pay $500 million in civil and criminal fines. The settlement is its largest-ever with a generic drugmaker over drug...
  • Artificially ripened Alphonso mangoes destroyed by FDA March 23, 2013

    Nashik: Artificially ripened Alphonso mangoes worth Rs 1.25 lakh were destroyed by the Food and Drugs Administration (FDA) at a local fruit market here, official sources said on Saturday. Around 1,400 kilos of Alphonso mangoes worth Rs 1.25 lakh were seized from a shop at Sharadchandra fruit market here on...
  • India is second largest drug exporter to US: FDA January 9, 2013

    Washington: The Food and Drug Administration (FDA) runs two offices in India to monitor the quality of foods and drugs made in India, the second largest drug exporter and the seventh largest food exporter to the US. Nearly one quarter of the spices, oils and food colourings used in the...
  • US: FDA okays new drug that fights drug-resistant TB January 5, 2013

    Mumbai: It's a breakthrough. A new line of treatment for multi-drug resistant (MDR) tuberculosis has been approved by the US Food and Drug Administration for the first time in 40 years. Tested on 440 patients in the US in two phase-II clinical trials, the drug Sirturo could prove to be...
  • US approves first pill to help prevent HIV July 17, 2012

    Washington: The Food and Drug Administration on Monday approved the first drug shown to reduce the risk of HIV infection, the latest milestone in the 30-year battle against the virus that causes AIDS. The agency approved Gilead Sciences' pill Truvada as a preventive measure for healthy people who are at high...
  • US approves HIV prevention pill July 17, 2012

    In a big breakthrough in HIV research, the US Food and Drugs Authority on Tuesday gave the nod for a pill that prevents HIV. ...
  • US: FDA approves first home-test kit for HIV July 7, 2012

    Washington: The Food and Drug Administration has approved the first over-the-counter HIV test, allowing Americans to test themselves for the virus that causes AIDS in the privacy of their homes. The OraQuick test detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return...
  • NRI couple pleads guilty for selling fake drugs May 17, 2011

    Washington: An Indian-American couple in New Jersey has pleaded guilty before a US court for selling counterfeit prescription drugs made in India, federal authorities said. The couple, 47-year-old Nita Patel and 57-year-old Harshad Patel, offered 'generic' forms of patented pharmaceutical products for sale over the internet, the source of which was...
  • FDA probes Lilavati Hospital for fraud February 23, 2011

    Mumbai: The Food and Drug Administration has begun to investigate the quality of drugs purchased by Lilavati Hospital, just days after CNN-IBN exposed money-laundering at the hospital. CNN-IBN, in its report, had shown that Lilavati Hospital sourced medicines from 400 small individual medical stores, 250 of which are located in...
  • Regeneron pain drug put on clinical hold December 28, 2010

    Boston: Regeneron Pharmaceuticals Inc said on Monday that US regulators placed the company's experimental pain drug for osteoarthritis on clinical hold after a patient in another company's trial developed a serious bone disorder. Regeneron said it and its partner, Sanofi-Aventis SA, were informed late last week by the US Food...
  • Abbott recalls millions of testing strips December 23, 2010

    Washington: The Food and Drug Administration said Wednesday that Abbott Laboratories is recalling up to 359 million testing strips used by diabetics because they can give falsely low blood sugar readings. The testing strips are used to help diabetes patients check their blood sugar levels. But the FDA says the...
  • FDA to review growth hormone safety, follows EU December 23, 2010

    Washington: US health officials are taking a closer look at recombinant human growth hormone products made by Pfizer, Novartis and other drugmakers to see whether they increase the risk of death. The move comes on the heels of a French study that found certain children given the hormone had "a small...
  • U S advisers back first new diet pill December 8, 2010

    Silver Spring Maryland: The first new weight-loss pill in a decade moved closer to US approval on Tuesday, when a panel of expert advisers backed Orexigen Therapeutics's Contrave despite heart risk concerns. It was the third new weight-loss drug to come before U.S. regulators this year, the Food and Drug...
  • Tall claims in Complan's ad challenged July 9, 2010

    Nagpur: The Maharashtra Food and Drug Administration has taken Heinz India to court over an advertisement for its health drink Complan. The advertisement claims the drink can add two inches to a child's height. The FDA chargesheet, naming seven officials of Heinz India, calls it an exaggerated advertisement. In an...
  • Is 'Female Viagra' safe? US to know today June 19, 2010

    A Food and Drug Administration committee in the US will today decide on its safety and effectiveness. ...
  • US approves H1N1 vaccine, shots to be ready in a month September 17, 2009

    Washington: US Food and Drug Administration on Tuesday approved a vaccine designed to protect against the swine flu and hopes to make it available within a month. The regulator approved the vaccine manufactured by four different drug companies and said the first batches of shots should be available in the US...
  • FDA allows access to morning-after pill for US teens April 23, 2009

    Washington: The "morning-after pill" will be available without a prescription to women 17 and older, the US Food and Drug Administration said on Wednesday. The minimum age has been 18. PlanB, also called the morning-after pill, is intended to prevent pregnancy after unprotected sex. On March 23, a federal court ordered that...
  • US FDA accuses Ranbaxy of falsifying drug data February 26, 2009

    Washington: The US Food and Drug Administration (FDA) has halted review of drug applications from Indian drug major Ranbaxy's Himachal Pradesh plant, alleging that it falsified data and test results in approved and pending drug applications. Announcing the action on Wednesday, the FDA said it is continuing to investigate the matter...
  • US court withdraws motion against Ranbaxy October 8, 2008

    New Delhi: Department Of Justice has withdrawn its motion against Ranbaxy, says Pharma-news-asia.com. The motion claimed that Ranbaxy had submitted false and fabricated information to the FDA about the stability of its generic medications. But there is still a case on relating to an FDA alert on 30 Ranbaxy drugs. The sale...
  • Ranbaxy's US FDA case may hurt other Indian pharmas September 18, 2008

    New Delhi: Pharma major Ranbaxy is in trouble again with US FDA. Two months ago, CEO Ranbaxy had told mediapersons, "In terms of the matter with the FDA and the DOJ, this is nothing new." Indian Bureau Chief, PharmaNewsAsia.com, Vikas Dandekar said, "In July, the dept of justice had given...
  • US bans Ranbaxy's drugs, company 'disappointed' September 17, 2008

    New Dekhi: India's largest pharmaceutical company Ranbaxy Laboratories Limited expressed its disappointment over a decision by the US Food and Drug Administration to ban more than 30 of its generic drugs made at two of its factories at Dewas and Paonta Sahib. The company issued a press statement on Wednesday morning...
  • US FDA bans dozens of Ranbaxy drugs September 17, 2008

    Washington: U.S. health officials have banned dozens of medications made by Ranbaxy Laboratories Ltd after the generic drugmaker failed to fix numerous problems with its manufacturing operations, including record-keeping and other procedural issues. The list of banned drugs includes popular antibiotics and cholesterol medicines made by India's drug giant Ranbaxy...