Shire announced on 23 June 2012 that it had lost its battle to protect its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts). FDA approved the abbreviated new drug application (ANDA) from Actavis, a unit of US generics company Watson Pharmaceuticals, for the ADHD drug on 22 June 2012.
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Generics
News
- FDA approves generic teriparatide and levetiracetam
- 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
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
News
- EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya
- FDA approves bevacizumab biosimilar Jobevne
- EMA recommends nine biosimilars for approval including trastuzumab and denosumab
- Australia biosimilar approvals in early 2025
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