FDA and EMA launch parallel scientific advice pilot program for complex generics

7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...

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A priority review voucher program to fuel generic drug development

6 July 2023 - Millions of Americans report that they are unable to fill their prescriptions or are not taking their ...

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NATCO files generic olaparib tablets in US

13 February 2023 - NATCO Pharma announces submission of abbreviated new drug application containing a paragraph IV certification with the ...

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A “method of use” to prevent generic and biosimilar market entry

25 January 2023 - A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny ...

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An innovation surcharge to fund the repurposing of generic drugs

10 November 2022 - The use of generic drugs continues to increase, generating substantial savings for purchasers and improving affordable access ...

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Bausch Health responds to Norwich Pharmaceuticals tentative FDA approval for a 200 mg rifaximin

9 September 2022 - Bausch Health and its gastro-enterology business Salix Pharmaceuticals today responded to the US FDA's tentative approval ...

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Akorn announces FDA has approved generic cetrorelix acetate

16 August 2022 - Akorn announces that it received FDA approval for a generic version of cetrorelix acetate 250 mcg ...

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Lupin receives tentative approval from U.S. FDA for ivacaftor tablets

8 June 2022 - Lupin today announced that it has received tentative approval from the United States FDA for its ...

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Sun Pharma announces US FDA approval for generic mesalamine extended release capsules

12 May 2022 - Sun Pharmaceutical Industries today announced that it has received final approval from U.S. FDA for its ...

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Eton Pharmaceuticals announces FDA approval of cysteine hydrochloride injection

11 April 2022 - Eton Pharmaceuticals today announced that it has received final approval from the U.S. FDA for its cysteine ...

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Amphastar receives FDA approval for ganirelix acetate injection

8 April 2022 - Amphastar Pharmaceuticals announced that the U.S. FDA has approved the Company's abbreviated new drug application for ganirelix ...

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Curium announces FDA approval of a generic version of DaTscan (Ioflupane I 123 injection) in the U.S.

5 April 2022 - Curium announced today that its generic version of DaTscan (Ioflupane I 123 injection) was approved on 30 ...

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FDA approves first generic of Symbicort to treat asthma and COPD

15 March 2022 - Agency supports development of complex generic drug-device combination product to improve competition and access to more affordable ...

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Teva announces launch of a first generic version of Revlimid (lenalidomide capsules) in the U.S.

7 March 2022 - Teva Pharmaceuticals announced today the launch of a first generic version of Revlimid (lenalidomide capsules), in 5 ...

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Approved first generic for Apokyn injection cartridges requires separately packaged pen

24 February 2022 - The U.S. FDA has approved the first generic of Apokyn (apomorphine hydrochloride injection) drug cartridges to ...

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