Latest Articles in Regulatory
Delhi HC Dismisses Plea Seeking Ban On Anti-Tobacco Ad Campaign At Cinemas
The Petitioner, being a non-smoker and not a consumer of any tobacco products, is wrongfully subjected to the compulsory watching of these graphic images in the anti-tobacco health spots during a film in the cinema hall and during TV programmes at home
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Akums Gets Fixed Drug Combination Approval From DCGI For Erectile Dysfunction
Tamsulosin is primarily used when an enlarged prostate impedes normal urine flow and bladder emptying. Conversely, Tadalafil's mechanism of action supports the development of a naturally induced erection, contingent upon sexual stimulation
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Strides Pharma Gets Tentative Approval For Treatment For HIV
Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate tablets are a complete regimen for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs
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Zydus Gets Final Approval For A Hormonal Transdermal Patch From USFDA
Ahmedabad-based Zydus Lifesciences has received final approval from the United States Food and Drug Administration for Norelgestromin and Ethinyl Estradiol Transdermal system, 150mcg /35mcg per day
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DCGI Issues Alert On Abbott's Digene Gel For Quality; Abbott Voluntarily Recalls Product In India
The Drug Controller General Of India (DCGI) Dr Rajeev Raghuvanshi has red-flagged a Digene Gel product manufactured by the pharmaceutical company Abbott India. In a letter dated 31 August 2023, the DCGI issued an alert calling the impugned product 'unsafe' and the use of which may result in adverse
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WHO Warns Of A Spurious Rare Disease Drug Defitelio Floating In India
Defitelio (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy
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Zydus Gets Final Nod For An Antibacterial Drug From USFDA
Ahmedabad-based Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Erythromycin Tablets USP, 250 mg and 500 mg a generic equivalent of US reference listed drug, Erythromycin Tablets
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Zydus Receives Approval From USFDA For Isotretinoin Capsules
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India)
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Glenmark Pulls Back 1,200 Bottles Of Hypertension Drug From US
As per the US Food and Drug Administration (USFDA), Glenmark Pharmaceuticals is in the process of recalling 1,200 bottles of a generic drug which is used in the treatment of high blood pressure, in the US market due to a manufacturing fault
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Gland Pharma Gets 2 Observations On Form 483 In A Pre-market Inspection By USFDA
Gland Pharma informed that the USFDA inspected the Pashamylaram Facility at Hyderabad from 23 August 2023 to 26 August 2023
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