Medical technology company Becton Dickinson announced on 28 March 2013 that FDA had approved the first drug in its line of prefilled generic injectables. This can only be good news for FDA who has been fighting to alleviate drug shortages in the US, most of which are due to shortages in generic sterile injectables.
- INICIO
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Genéricos
Novedades
- 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
Investigación
- 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
General
- EMA launches European shortages monitoring platform to tackle persistent medicine shortages
- Crecimiento de medicamentos genéricos en Brasil y Venezuela
- Penetración de los medicamentos genéricos en México y Brasil
- FDA releases one-year progress report for the Generic Drug Cluster
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Biosimilares
Novedades
- EC approves eight biosimilars, eight more await final authorization
- Canada approves first omalizumab biosimilar Omlyclo
- EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti
- Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada
Investigación
- Resultados positivos del criterio principal de seguridad y eficacia de AVT05 (biosimilar propuesto de golimumab)
- ¿Están en riesgo los biosimilares intercambiables?
- Estudios comparativos de eficacia: ¿dónde estamos ahora?
- Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study
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