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RSS FeedPosted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 02 Feb 2022
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 ...
Posted by Michael Wonder on 09 Nov 2021
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 ...
Posted by Michael Wonder on 19 Oct 2021
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 ...
Posted by Michael Wonder on 02 Sep 2021
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 ...
Posted by Michael Wonder on 22 Jun 2021
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 ...
Posted by Michael Wonder on 21 Jun 2021
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 ...
Posted by Michael Wonder on 01 Jun 2021
Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing
1 June 2021 - Lannett today announced the U.S. FDA has accepted the abbreviated new drug application for fluticasone propionate and ...
Posted by Michael Wonder on 22 Mar 2021
Oakrum Pharma and Aucta Pharma announce U.S. FDA approval of generic version of Jadenu Sprinkle (deferasirox granules)
22 March 2021 - Oakrum Pharma in collaboration with Aucta Pharmaceuticals announced today the U.S. approval of a generic version of ...
Posted by Michael Wonder on 11 Feb 2021
FDA’s generic drug program in 2020 helped ensure availability of high quality, affordable drugs amid COVID-19
11 February 2021 - Generic drugs play a vital role in facilitating access to lifesaving medicines for Americans and remain a ...
Posted by Michael Wonder on 14 Jan 2021
Amneal launches generic abiraterone acetate 500 mg tablets following ANDA approval by FDA
8 January 2021 - Amneal Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its ...
Posted by Michael Wonder on 29 Dec 2020
FDA approves first generic of drug used to treat severe hypoglycaemia
28 December 2020 - Today, the U.S. FDA approved the first generic of glucagon for injection USP, 1 mg/vial packaged in ...
Posted by Michael Wonder on 20 Dec 2020
Hikma launches generic Advair Diskus following FDA approval
17 December 2020 - Hikma Pharmaceuticals announces it has received FDA approval for and launched its generic version of GlaxoSmithKline’s ...
Posted by Michael Wonder on 17 Dec 2020
FDA updates list of off-patent, off-exclusivity drugs without an approved generic
17 December 2020 - Today, the U.S. FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved ...
Posted by Michael Wonder on 01 Nov 2020
A CDER study of factors that may predict the likelihood of generic drug marketing applications
28 October 2020 - The investigators compiled proprietary data related to abbreviated new drug applications and other internal or public ...