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RSS FeedPosted by Michael Wonder on 26 Dec 2024
FDA approves first generic of once daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes
23 December 2024 - Today, the US FDA approved the first generic referencing Victoza (liraglutide injection) 18 mcg/3 mL, a ...
Posted by Michael Wonder on 14 Aug 2024
The FDA should withdraw approval of more than 400 tainted medicines
12 August 2024 - When the FDA learned that a testing facility in India had submitted fraudulent data for more ...
Posted by Michael Wonder on 07 Feb 2024
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 ...
Posted by Michael Wonder on 07 Jul 2023
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 ...
Posted by Michael Wonder on 14 Feb 2023
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 ...
Posted by Michael Wonder on 26 Jan 2023
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 ...
Posted by Michael Wonder on 07 Dec 2022
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 ...
Posted by Michael Wonder on 09 Sep 2022
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 ...
Posted by Michael Wonder on 17 Aug 2022
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 ...
Posted by Michael Wonder on 09 Jun 2022
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 ...
Posted by Michael Wonder on 16 May 2022
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 ...
Posted by Michael Wonder on 11 Apr 2022
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 ...
Posted by Michael Wonder on 10 Apr 2022
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 ...
Posted by Michael Wonder on 05 Apr 2022
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 ...
Posted by Michael Wonder on 15 Mar 2022
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 ...