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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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Generics
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China to relax generic drug import laws
The government in China has stated that small quantities of generic medicines that are legal in foreign countries will no longer be classed as “fake drugs”.
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Novo Nordisk files lawsuit against Mylan for generic application
The two pharmaceutical companies are facing a legal battle after Mylan filed a new drug application for a generic of Novo Nordisk’s Victoza.
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FDA approves nine generics for Lyrica drug
The FDA has announced that it has granted approval to the first nine generic drug applications for Pfizer’s Lyrica treatment.
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China announces generic drug list to reduce pharmaceutical costs
Chinese government introduces initiative to enable generic drugs to enter market and reduce prices.
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US drugmakers allegedly collude on generic price hikes
A coalition of 43 attorneys general allege generic drug manufacturers colluded, overcharging US states and consumers billions.
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Japanese pharma market set for strong growth in 2019
The report, published from CPhI Japan 2019, highlights the country as the second fastest growing mature market for solid dose drugs.
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ESMO drives EU-level action to tackle shortages of essential medicines
Shortages of inexpensive, essential medicines: calling for tangible political commitments in the EU...
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Big pharma blamed for skyrocketing US drug prices
Executives blamed high drug prices on the drugmakers and their pursuit of profits...
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Heart drugs free from carcinogens identified as recalls drag on
The Food and Drug Administration has released a list of 40 drugs used to treat hypertension and heart failure that don’t contain any known carcinogens...
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New generic valsartan approved to address shortages
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers...
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Indian government plans to colour code generics
Colour-coded generics might help consumers differentiate between generics and branded medicines...
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EU measures in support of generic pharmaceuticals producers
The EU is adopting new rules which should boost the competitiveness of EU producers of generic medicines and biosimilar products...
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FDA grant to help increase generic drugs delivered intravaginally or by IUD
Of the 21 drugs designed for delivery directly to the female genital tract, only four have a cost-effective, generic equivalent...
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Rising drug prices linked to older products, study finds
The rising costs of brand-name drugs is largely driven by inflation in the prices of widely used existing drugs, according to a study published in the January issue of Health Affairs...
