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  • US drug regulator denies interference over Pfizer vaccine Dec 12, 2020 09:54 PM IST

    US drug regulator denies interference over Pfizer vaccine

    The FDA issued an emergency use authorization for the two-dose regimen late on Friday night following reports President Donald Trump had threatened to fire the head of the agency if he didn't act that day.

  • US FDA asks COVID-19 vaccine developers for two months follow-up data Oct 06, 2020 09:03 PM IST

    US FDA asks COVID-19 vaccine developers for two months follow-up data

    The agency's advise was released on Tuesday as part of documents posted ahead of a meeting of its expert panel later this month to discuss coronavirus vaccines under development.

  • Raining USFDA warning letters to Indian drug sites point to intensified regulatory risk Nov 25, 2019 08:55 PM IST

    Raining USFDA warning letters to Indian drug sites point to intensified regulatory risk

    Around 18 pharma companies had received USFDA warning letters for their Indian plants in 2019 alone, these were more than half of the all the warning letters issued by the regulatory agency.

  • Aurobindo Pharma gets USFDA nod for pain reliever Ibuprofen Jul 02, 2018 11:48 AM IST

    Aurobindo Pharma gets USFDA nod for pain reliever Ibuprofen

    Aurobindo Pharma said the estimated market size of ibuprofen capsules OTC is USD 164 million for the twelve months ending March 2018.

  • Cipla gets USFDA nod for generic Testosterone Cypionate injection Jun 21, 2018 03:34 PM IST

    Cipla gets USFDA nod for generic Testosterone Cypionate injection

    The company has received final approval for its abbreviated new drug application (ANDA) for Testosterone Cypionate injection in the strengths of 100mg/ml and 200mg/ml from the US Food and Drug Administration (USFDA), Cipla said in a filing to BSE.

  • USFDA approves first product from Glenmark's US plant Jun 19, 2018 04:29 PM IST

    USFDA approves first product from Glenmark's US plant

    The US Food and Drug Administration (USFDA) has provided its first supplemental Abbreviated New Drug Application (ANDA) approval for the company's plant in Monroe, Glenmark said in a statement.

  • Sanofi and Regeneron's eczema drug gets FDA approval Mar 29, 2017 07:48 PM IST

    Sanofi and Regeneron's eczema drug gets FDA approval

    Global healthcare company Sanofi and Regeneron Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injection to patients suffering from chronic and debilitating form of eczema.

  • Aurobindo Pharma gets final USFDA approval Mar 21, 2017 08:52 AM IST

    Aurobindo Pharma gets final USFDA approval

    "Aurobindo's Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets are the AB rated generic equivalent of Reckitt Benckiser's Mucinex DM tablets. The product will be launched in Q1 FY18 (in US)," it said.

  • Zydus Cadila gets USFDA nod to market muscle relaxant in US Mar 08, 2017 11:54 AM IST

    Zydus Cadila gets USFDA nod to market muscle relaxant in US

    "The company has received final approval from the US Food and Drug Administration (USFDA) to market tizanidine hydrochloride capsules, USP in strengths of 2mg, 4mg and 6mg," Zydus Cadila said in a regulatory filing today.

  • Breakthrough drug for Huntington disease drives Neuland up 20% Mar 01, 2017 12:39 PM IST

    Breakthrough drug for Huntington disease drives Neuland up 20%

    Analysts believe that Neuland Labs is a supplier of API (active pharma ingredient) to Teva for this drug, which is used in the therapy of Huntington Disease, a disorder related to tardive dyskinesia. If the new drug application is accepted, Neuland will be a key beneficiary.

  • Lupin gets FDA nod for generic version of Suprep Feb 28, 2017 11:48 AM IST

    Lupin gets FDA nod for generic version of Suprep

    Suprep follows a split dose regime and Lupin has got approval for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, all of which are taken to cleanse the colon before colonoscopy in adults. Suprep Bowel Prep Kit has a market of $207 mn in the USA.

  • Jubilant gets USFDA nod for generic anti-fungal capsules Feb 27, 2017 01:58 PM IST

    Jubilant gets USFDA nod for generic anti-fungal capsules

    The company has received approval from the US Food and Drug Administration (USFDA) for Itraconazole capsules, a generic version of Janssen Pharmaceuticals' Sporanox, Jubilant Life Sciences said in a regulatory filing.

  • Natco Pharma did not follow quality control measures: USFDA Jan 25, 2017 02:36 PM IST

    Natco Pharma did not follow quality control measures: USFDA

    The US drug regulator has made six observations after the completion of inspection of its Kothur formulation facility in Telangana, Natco said today in a statement.

  • Lupin launches generic morphine sulfate tablets in US Jan 13, 2017 12:44 PM IST

    Lupin launches generic morphine sulfate tablets in US

    The company said it has launched the morphine sulfate ER Tablets in strengths of 15 mg, 30 mg, 60 mg, 100 mg and 200 mg having received an approval from the US Food and Drug Administration (USFDA).

  • USFDA to re-audit three Dr Reddy's plants Jan 12, 2017 03:34 PM IST

    USFDA to re-audit three Dr Reddy's plants

    US Food and Drug Administration (USFDA) will re-audit three manufacturing facilities of Dr Reddy's Laboratories in the current quarter.

  • Base effect in metals, PSBs may aid Q3 earnings: Edelweiss Jan 09, 2017 10:00 AM IST

    Base effect in metals, PSBs may aid Q3 earnings: Edelweiss

    Valuation in the information technology sector is favourable but challenges in terms of earnings and uncertainty on Trump‘s policies make them good picks only on bad days, says Nischal Maheshwari, Head - Institutional Equities at Edelweiss Securities.

  • Natco may launch leukemia drug in US mkt on or before Nov 2019 Jan 06, 2017 02:22 PM IST

    Natco may launch leukemia drug in US mkt on or before Nov 2019

    According to a statement issued by the city-based drug-maker, the drug will be launched along with its marketing partner Breckenridge Pharmaceutical Inc and will have 180-days exclusivity.

  • USFDA issues warning letter to Wockhardt's Ankleshwar plant Jan 04, 2017 02:44 PM IST

    USFDA issues warning letter to Wockhardt's Ankleshwar plant

    USFDA has already banned import of products from the facility into the US market since August 5, 2016.

  • Divis at 28-month low on regulatory woes; stock not de-rated yet Dec 26, 2016 10:18 AM IST

    Divis at 28-month low on regulatory woes; stock not de-rated yet

    Divis' Unit 2 facility was last inspected in February 2016 with no form 483s being issued. The company's Unit 1 facility (located at Hyderabad) has no pending 483s (but was last inspected in 2014).

  • Earnings growth of ex-financials may come down to 0% in Q3 & Q4 Dec 23, 2016 09:44 AM IST

    Earnings growth of ex-financials may come down to 0% in Q3 & Q4

    The demonetisation drive has taken a toll on the market and Anish Damania of IDFC Securities says that the market may not see recovery soon and there will be three quarters of dismay.

  • Why pharma stocks lost their safe haven appeal this year Dec 21, 2016 01:41 PM IST

    Why pharma stocks lost their safe haven appeal this year

    Pharmaceutical stocks have traditionally been considered defensive safe havens because demand for medicines doesn‘t depend on the economic cycle

  • Demonetisation: Organised business to gain bigger market share: Dipen Sheth Dec 19, 2016 10:17 AM IST

    Demonetisation: Organised business to gain bigger market share: Dipen Sheth

    "You can get better tax compliance, arguably lower corruption. If you have higher tax compliance, you might get lower tax rates," Dipen Sheth said.

  • US FDA finds quality control problem at Sun Pharma's Halol plant Dec 13, 2016 12:34 PM IST

    US FDA finds quality control problem at Sun Pharma's Halol plant

    Earlier this month, Sun said it had been informed by the US health regulator of more concerns about its plant in the western Indian state of Gujarat after a recent inspection, but details of the violations were unclear at the time.

  • Sun Pharma says US finds more concerns at Halol plant Dec 07, 2016 02:38 PM IST

    Sun Pharma says US finds more concerns at Halol plant

    The latest notice, a Form 483, was issued to Sun after the FDA completed an inspection of the Halol plant on Dec. 1, the company said. Such a notice is issued when the FDA finds that conditions at a drug plant violate US rules.

  • Indian drug regulator tightens leash; terms 200 cos 'high risk' Nov 30, 2016 08:32 AM IST

    Indian drug regulator tightens leash; terms 200 cos 'high risk'

    In the past few weeks, CDSCO has inspected around 135 manufacturing plants and laboratories all over the country with help from state regulators. The regulator's main focus is to assess the risk and quality standards of manufacturing units.

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