Zydus Lifesciences on Monday said it has launched a generic medication to treat overactive bladder in the US market. The company has launched Mirabegron extended-release tablets in strength of 25 mg in the US market after having received final approval from the US Food and Drug Administration (USFDA), Zydus Lifesciences said in a regulatory filing.
The US Food and Drug Administration (USFDA) conducted the cGMP (Current Good Manufacturing Practice) inspection at the facility from March 18-27, 2024, the company said in a regulatory filing.
Co gets tentative US FDA approval for Letermovir tablets, used to prevent diseases in bone marrow or kidney transplant patients
The drug will target specific genetic mutations prevalent in certain types of cancers, paving the way for a more tailored and effective treatment approach, the company said in a stock exchange filing. The drug will target specific genetic mutations prevalent in certain types of cancers, paving the way for a more tailored and effective treatment approach.
Zydus will enter a competitive field, with an FDA decision on CymaBay's PBC drug due in August. Gilead Sciences announced its acquisition of CymaBay for $4.3 billion earlier in February. Saroglitazar, currently in a mid-to-late-stage trial for PBC, is also being tested for Metabolic Dysfunction-Associated Steatohepatitis (MASH), a type of fatty liver disease."
Approved by the Indian drug regulator in May 2023, sovateltide can be administered within 24 hours for the treatment of ischemic stroke, almost five times more than the narrow time window of 4-5 hours offered by current treatment options like tissue plasminogen activator (TPA) called thrombolytic drugs that dissolve the clots that cause strokes. An ischemic stroke is a medical emergency that occurs when blood supply to part of a brain is blocked or reduced.
Global biotech giant Roche alleges Indian drug maker Zydus Lifesciences imported several vials of Perjeta, a breast cancer drug from Germany, for its clinical trials in India during August and September 2022. However, the Swiss firm claims such supplies were not from its official supply chain. Roche fears the vials may be of questionable quality, possibly compromised and spurious. Zydus has refuted all the allegations and termed them as baseless and unfounded.
As per IQVIA data, the product had an annual sales of USD 85 million in the US. Shares of Zydus were trading 2.27 per cent down at Rs 735.30 apiece on the BSE.
Zydus Lifesciences reported that its subsidiary, Zydus Healthcare Ltd, has received an income tax notice demand of Rs 284.58 crore for the assessment year 2023-2024. The demand is attributed to apparent mistakes in the processing of the return of income. Zydus Lifesciences believes that once rectifications are made, the entire demand will be deleted.
Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat. The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023.
The approval by the US Food and Drug Administration (USFDA) is for Cyclophosphamide capsules of strengths 25 mg and 50 mg, Zydus Lifesciences said in a regulatory filing.
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