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Latest Articles in regulatory

Interim Budget Generates Serious Questions From India's FinMin

The shortest budget, very high on rhetoric, throws up serious questions which the discerning public demands answers, writes JK Dadoo

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Innovative Optical Technology Receives Second Patent Boost In India

This additional patent solidifies and augments the original invention, unveiling unique features with the potential to enhance precision and productivity across various applications

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Zydus Lifesciences Receives USFDA Nod For Generic Gabapentin Tablets

The company received final approval for manufacturing and marketing Gabapentin tablets in 300 mg and 600 mg strengths, making it the first to receive such approval

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Alembic Pharmaceuticals Gets USFDA Approvals For Eight Drug Applications

The approvals include five final approvals for medications such as Selexipag Tablets (multiple strengths), Dapsone gel (7.5 per cent), Fluorouracil Injection USP 5g/100mL (50 mg/mL), Carmustine for Injection USP 100 mg/vial, and Acyclovir Cream (5 per cent)

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Lupin Receives FDA Approval For Generic Equivalent Of Alrex Ophthalmic Suspension

This approval positions Lupin to market a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2 per cent, produced by Bausch & Lomb

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FDA Requests Additional Study For Amgen's Lumakras

Lumakras, an oral drug, is specifically designed to target a mutated form of the KRAS gene, occurring in approximately 13 per cent of non-small cell lung cancers, the most prevalent form of lung cancer, and less frequently in some other solid tumours

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FDA Seizes Counterfeit Ozempic: Thousands Of Fake Diabetes Drug Units Circulate, Health Warning Issued

Reportedly, Novo Nordisk, the manufacturer of Ozempic, is collaborating with the FDA to conduct testing on the seized counterfeit shots

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AstraZeneca India Receives Approval For Triple Combination Inhaler For COPD Treatment

In comparison to currently available dual therapies, this triple combination therapy is proven to considerably lower the rate of moderate to severe exacerbations, and mortality rates, and increase lung function

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Lupin Secures USFDA Nod For Generic Chantix Tablets to Aid Smoking Cessation

Varenicline tablets, 0.5 mg, and 1 mg will serve as a generic equivalent to Chantix Tablets, 0.5 mg, and 1 mg which will be produced at Lupin's unit in Pithampur

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Health Canada Clears Novavax's Omicron-Targeted Vaccine For Children Above 12yrs

The World Health Organization (WHO) had previously granted emergency use authorisation for the vaccine last month, which is tailored to address a descendant of the XBB lineage of the coronavirus

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