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RSS FeedPosted 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 Apr 2021
The TGA claims Tenofovir Emtricitabine Sandoz is a first generic but is it?
22 April 2021 - Closer examination suggests otherwise. ...
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 ...
Posted by Michael Wonder on 21 Oct 2020
FDA approves fewer generics in FY2020, ending record streak
21 October 2020 - After four straight years of posting record numbers of abbreviated new drug application approvals, the US ...
Posted by Michael Wonder on 19 Oct 2020
Glenmark Pharmaceuticals receives ANDA approval for sirolimus 0.5 mg, 1 mg and 2 mg tablets
19 October 2020 - Glenmark Pharmaceuticals has received final approval by the United States FDA for sirolimus 0.5 mg, 1 mg ...
Posted by Michael Wonder on 22 Sep 2020
Hikma updates on ANDA for generic Advair Diskus
22 September 2020 - Hikma Pharmaceuticals announces that it has received a minor complete response letter from the US FDA ...
Posted by Michael Wonder on 03 Sep 2020
California may be the first state to develop its own generic drugs
1 September 2020 - California is poised to become the first state to develop its own line of generic drugs, ...
Posted by Michael Wonder on 19 Aug 2020
Mylan brings critical access to the multiple sclerosis community by launching a more affordable treatment option through a first generic to Tecfidera
19 August 2020 - Mylan today announced the launch of the first FDA approved therapeutically equivalent, substitutable generic of Biogen's ...
Posted by Michael Wonder on 13 Aug 2020
Drug prices fall in Switzerland but generics remain expensive
13 August 2020 - Switzerland is narrowing the gap with other European countries when it comes to the cost of medicines. ...