Office of Generic Drugs 2021 Annual Report

14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...

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FDA approves first generic of Restasis

2 February 2022 - The U.S. FDA has approved the first generic of Restasis (cyclosporin ophthalmic emulsion) 0.05% single use vials ...

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Billionaire Mark Cuban opens online pharmacy to provide affordable generic drugs

20 January 2022 - Billionaire investor Mark Cuban launched an online pharmacy Thursday that offers more than 100 generic drugs at ...

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FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics

9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...

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The hurried push by Congress to address drug costs shouldn’t undermine the vast savings from generics and biosimilars

6 November 2021 - Americans rightfully expect Congress to address the ever increasing prices of brand-name prescription drugs. ...

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Repurposing of authorised medicines: pilot to support not for profit organisations and academia

28 October 2021 - EMA and the Heads of Medicines Agencies are launching a pilot project to support the repurposing ...

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Patient and payer incentives to use patented brand name drugs vs authorised generic drugs in Medicare Part D

18 October 2021 - This cross-sectional study of Medicare formulary and pricing data for quarter 3 of 2020 found that most ...

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Strategies for generic/biosimilar market entry in Australia

19 October 2021 - After surviving the Great Patent Cliff of 2011–2016, the pharma/biopharma industry finds itself in the Second Great ...

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Dr. Reddy's Laboratories announces approval for lenalidomide capsules from the U.S. FDA

19 October 2021 - Dr. Reddy’s Laboratories today announced the final approval of its abbreviated new drug application for lenalidomide 2.5 ...

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FDA reaches milestone in competitive generic therapy drug approvals

2 September 2021 - This week, the FDA reached the milestone of approving more than 100 generic drug applications with a ...

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Natco Pharma (Canada) announces the launch of Nat-Lenalidomide capsules, the first generic alternative to Revlimid

1 September 2021 - Nat-Lenalidomide expands affordable treatment options for patients with multiple myeloma and patients with transfusion-dependent anaemia due to ...

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'New regulation limiting generic drugs will change industrial paradigm'

27 July 2021 - The Korea Pharmaceutical and Bio-pharma Manufacturers Association said the revision of the Pharmaceutical Affairs Act to ...

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TGA approves first generic pomalidomide

23 June 2021 - The TGA has approved first generic version of Celgene's Pomalyst. ...

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Acrux receives approval from the FDA for its generic version of Jublia

22 June 2021 - Acrux is pleased to announce that the US FDA has granted approval of the Company’s generic version ...

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Factors associated with generic drug uptake in the United States, 2012 to 2017

19 June 2021 - In the United States, brand-name prescription drugs remain expensive until market exclusivity ends and lower cost generics ...

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