Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate cream, 0.05%, a generic version of Diprolene® AF, and generic amlodipine and atorvastatin tablets (Caduet®). It has also received tentative FDA approval to market generic esomeprazole magnesium delayed-release capsules (Nexium®). This brings the total approvals of the Zydus group to 247, and it has so far filed over 330 abbreviated new drug applications (ANDAs) since the filing process commenced in the 2003‒2004 financial year.
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Generics
News
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
Research
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
- Trajectories of prices in generic drug markets
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Biosimilars
News
- EMA recommends approval of trastuzumab biosimilar Herwenda
- FDA approves first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first aflibercept and tocilizumab biosimilars
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