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US Food and Drug Administration (USFDA)

Zydus gets USFDA nod to produce generic prostate cancer drug

Zydus gets USFDA nod to produce generic prostate cancer drug

Sat, Sep 28, 2024

The group now has 400 approvals and has filed over 465 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

Biocon gets 4 observations from USFDA for Bengaluru API facility

Biocon gets 4 observations from USFDA for Bengaluru API facility

Sat, Sep 28, 2024

The US Food and Drug Administration (USFDA) conducted a surveillance inspection of the API facility (Site 2), located at Bengaluru from September 23- 27, 2024.

Lupin gets 6 observations from USFDA for Pithampur plant

Lupin gets 6 observations from USFDA for Pithampur plant

Sat, Sep 28, 2024

The US Food and Drug Administration (USFDA) inspected the company's Pithampur Unit-1 API and finished product manufacturing facility from September 16 to September 27, 2024.

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Dr Reddy's, Sun Pharma, Aurobindo recall products in US

Dr Reddy's, Sun Pharma, Aurobindo recall products in US

Sun, May 19, 2024

The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year.

Zydus unit gets 10 observations from USFDA after inspection

Zydus unit gets 10 observations from USFDA after inspection

Wed, Apr 24, 2024

The US Food and Drug Administration (USFDA) inspected the facility at Jarod near Vadodara from April 15 to April 23, the drug maker said in a regulatory filing.

US FDA approves Daiichi, AstraZeneca drug for treatment of solid tumors

US FDA approves Daiichi, AstraZeneca drug for treatment of solid tumors

Sat, Apr 06, 2024

The drug, sold under the brand name Enhertu, originally won US approval in late 2019 as a third-line treatment for HER-2-positive breast cancer patients, and the fresh approval opens the treatment across multiple HER2-expressing solid tumors.

Strides Pharma arm gets USFDA nod for generic Mycophenolate Mofetil oral suspension

Strides Pharma arm gets USFDA nod for generic Mycophenolate Mofetil oral suspension

Wed, Aug 30, 2023

The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing.

Lupin gets USFDA nod to market generic drug

Lupin gets USFDA nod to market generic drug

Fri, Aug 25, 2023

Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic product, used in the treatment of a lung disease, in the American market.

Sun Pharma recalls over 24K prefilled syringes of generic medication in the US due to a manufacturing issue

Sun Pharma recalls over 24K prefilled syringes of generic medication in the US due to a manufacturing issue

Sun, May 07, 2023

Drug major Sun Pharmaceutical Industries is recalling pre-filled syringes of a drug, used to treat infertility in women, in the US market due to a manufacturing issue, according to the US health regulator.

Zydus Lifesciences gets USFDA nod for generic medication

Zydus Lifesciences gets USFDA nod for generic medication

Mon, Apr 24, 2023

Zydus Lifesciences on Monday said it has received approval from the US health regulator to market a generic medication that is used to lower triglycerides, in the American market. The company has got the final approval from USFDA to market Icosapent Ethyl Capsules in strength of 0.5 g and 1 g.

Zydus gets USFDA final approval for Acetazolamide tablets

Zydus gets USFDA final approval for Acetazolamide tablets

Thu, Apr 06, 2023

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market its generic Acetazolamide tablets used in the treatment of glaucoma.

Zydus recalls over 55,000 bottles of generic drug in US amid failed impurities specifications

Zydus recalls over 55,000 bottles of generic drug in US amid failed impurities specifications

Sun, Mar 26, 2023

As per the latest enforcement report by the US Food and Drug Administration (USFDA), Zydus Pharmaceuticals (USA) Inc is recalling 21,936 (30 count) and 33,096 (100 count) bottles of Colchicine tablets, which are used to treat gout.

Zydus Lifesciences gets USFDA's nod to market generic version of Bortezomib

Zydus Lifesciences gets USFDA's nod to market generic version of Bortezomib

Tue, May 03, 2022

Zydus Lifesciences Ltd announced on Tuesday that the US Food and Drug Administration (USFDA) has given final approval to commercialize its generic version of Bortezomib for injection.

Lupin gets tentative USFDA nod for generic Azilsartan Medoxomil tablets to treat high BP

Lupin gets tentative USFDA nod for generic Azilsartan Medoxomil tablets to treat high BP

Fri, Dec 24, 2021

Homegrown pharmaceuticals major Lupin on Friday said it has received tentative approval from the US health regulator for its generic Azilsartan Medoxomil tablets used to treat high blood pressure.

Cipla gets USFDA nod for generic product

Cipla gets USFDA nod for generic product

Thu, Aug 12, 2021

Drug firm Cipla has received approval from the US health regulator to market Difluprednate Ophthalmic Emulsion in the American market.

Alembic Pharma's JV Aleor gets USFDA nod for generic skin conditions ointment

Alembic Pharma's JV Aleor gets USFDA nod for generic skin conditions ointment

Tue, Mar 05, 2019

According to IQVIA , Clobetasol Propionate ointment USP, 0.05 per cent, has an estimated market size of USD 63 million for twelve months ending December 2018, Alembic Pharmaceuticals said.

Sun Pharma receives USFDA nod ophthalmic solution used to treat dry eye disease

Sun Pharma receives USFDA nod ophthalmic solution used to treat dry eye disease

Thu, Aug 16, 2018

Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated, Abhay Gandhi, CEO, North America, Sun Pharma.

Orchid Pharma gets inspection report from US regulator

Orchid Pharma gets inspection report from US regulator

Mon, Jan 08, 2018

The company's stock closed 4.93% up on the BSE today

Glenmark launches generic version of cholesterol drug Zetia in US market

Glenmark launches generic version of cholesterol drug Zetia in US market

Mon, Dec 12, 2016

Glenmark and its partner Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe.

Marksans Pharma shares jump 11% on USFDA nod for allergic drug

Marksans Pharma shares jump 11% on USFDA nod for allergic drug

Mon, Sep 26, 2016

The company said that USFDA has granted not for an Abbreviated New Drug Application (ANDA) for Loratadine liquid filled capsules 10 mg.

Lupin shares fall 2% despite receiving approval for Acotiamide tablets

Lupin shares fall 2% despite receiving approval for Acotiamide tablets

Mon, Aug 22, 2016

Naresh Gupta, President, Lupin Limited said “We have a rich legacy of having introduced novel treatments to address unmet medical needs in the country. I am sure that the approval of Acotiamide would go a long way in addressing an otherwise common but unmet medical need for a safe and effective drug for the management of dyspepsia.”

Aurobindo Pharma gets USFDA approval for blood pressure drug; shares up over 1%

Aurobindo Pharma gets USFDA approval for blood pressure drug; shares up over 1%

Tue, Apr 26, 2016

The company received approval from USFDA for a generic version of blood pressure treatment drugs

Aurobindo Pharma receives USFDA approval for gastro reflux drug

Aurobindo Pharma receives USFDA approval for gastro reflux drug

Fri, Apr 22, 2016

The company said the launch of the product is based on the settlement terms/litigation outcome with AstraZeneca.

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