Alembic Pharmaceuticals receives US FDA’s tentative approval for Empagliflozin and Metformin…
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synjardy Tablets of…
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US FDA
US FDA working to restart on-site inspections during week of July 20
The FDA, which is working towards resuming on-site inspections around July 20, also determined that, for the foreseeable future,…
Cipla receives final approval for generic version of Shire’s Firazyr
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and…
Lupin recalls diabetes treatment drug in US
The company said that it is voluntarily recalling its Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000 mg…
Strides receives USFDA approval for headache drug
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules will be marketed by Strides Pharma in the US market
Unichem Labs gets US FDA nod to market muscle spasm tablets
The product is a generic version of Janssen Research and Development LLC's Flexeril tablets
Indian pharma firms recall medications from US market
Lupin and Marksans Pharma recall diabetes drugs while Alembic and Aurbindo recall medicines that treat mental disorders
FDA’s EUA benchmarks for COVID-19 vaccines remain ill-defined: GlobalData
Experts feel that COVID-19 vaccines should ideally demonstrate an upsurge in both neutralising antibody titres and cell-mediated…
US FDA approves GSK’s HIV drug for patients with limited options
The oral treatment from the company’s HIV unit, ViiV Healthcare, has been approved for adults whose HIV infection could not be…
Alembic Pharma gets US FDA nod for generic Doxycycline Hyclate tablets
The company's product is a generic version of Almirall's Acticlate tablets in the same strengths