FDA approves first generic of Daraprim

28 February 2020 - Agency continues to support competition in generic drugs, increasing patient access to more affordable medicines. ...

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Perrigo and Catalent announce FDA approval of Perrigo's AB-rated generic version of ProAir HFA

24 February 2020 - Perrigo and its partner, Catalent Pharma Solutions, today announced that the U.S. FDA has approved Perrigo's abbreviated ...

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FDA approves first generic of ProAir HFA

24 February 2020 - Agency supports development of complex generic drugs to improve competition and access to more affordable medicines. ...

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Teva announces FDA approval of ArmonAir Digihaler (fluticasone propionate) inhalation powder

24 February 2020 - Teva’s digital inhaler portfolio now includes products from three of the most commonly prescribed classes of ...

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Serving public health paramount in a successful 2019 for FDA’s generic drug program

19 February 2020 - Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system.  ...

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FDA touts generic drug research in 2019

19 February 2020 - The US FDA on Tuesday released a report detailing the scientific research carried out and funded ...

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FDA updates prioritization policy for original abbreviated new drug applications, amendments and supplements to maximise impact on public health

30 January 2020 - Today, the U.S. FDA is making critical updates to our policy for prioritising the review of ...

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U.S. targets drug pricing, no-poach deals for anti-trust action in 2020

15 January 2020 - Justice Department antitrust chief also promises decision on music licensing, criticizes states’ lawsuit against T-Mobile and Sprint. ...

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Generic makers will appeal ruling that allows California to proceed with law banning pay-to-delay deals

3 January 2020 - A federal judge dealt the pharmaceutical industry a setback by declining to block a new California ...

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FDA approves first generics of Eliquis

23 December 2019 - The U.S. FDA has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce ...

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FDA issues new analysis linking greater generic competition and lower generic drug prices

13 December 2019 - Greater competition among generic drug makers is associated with lower generic drug prices, according to a new ...

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Endo launches generic version of Afinitor (everolimus) tablets in the United States

10 December 2019 - Endo International today announced that one of its operating companies, Par Pharmaceutical, has received approval for and ...

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FDA approves first generics of Gilenya

5 December 2019 - The U.S. FDA has approved three applications for first generics of Gilenya (fingolimod) capsules for the ...

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Hikma completes its FDA response for generic Advair

27 November 2019 - Hikma Pharmaceuticals today announces that it has submitted to the US FDA its response to deficiencies in ...

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Teva, drug makers in talks with U.S. to end generics probes

26 November 2019 - Deferred prosecution agreements among resolutions discussed. ...

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