Blog
RSS FeedPosted by Michael Wonder on 08 Feb 2019
Generic drug approvals surge, but hundreds still aren't for sale
7 February 2019 - The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines
30 January 2019 - As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many ...
Posted by Michael Wonder on 30 Jan 2019
FDA approves first generic Advair Diskus
30 January 2019 - The U.S. FDA today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition
30 January 2019 - One of our key policy priorities is encouraging the timely development and approval of generics and ...
Posted by Michael Wonder on 16 Jan 2019
FDA approves first generic version of Sabril to help treat seizures in adults and paediatric patients with epilepsy
16 January 2019 - The U.S. FDA approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex ...
Posted by Michael Wonder on 16 Jan 2019
Amneal announces approval of rivastigmine transdermal system
14 January 2019 - Amneal Pharmaceuticals today announced that it has received FDA approval for a generic version of Exelon Patch ...
Posted by Michael Wonder on 13 Dec 2018
A method for approximating future entry of generic drugs
13 December 2018 - The paper by Beall and colleagues relates to the development and testing of a method for approximating ...
Posted by Michael Wonder on 13 Dec 2018
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on efforts to modernise generic drug labels while maintaining the efficiency of generic development
13 December 2018 - Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and ...
Posted by Michael Wonder on 13 Dec 2018
Authorized generic for Evzio (naloxone hydrochloride injection) to be available at a reduced list price of $178
12 December 2018 - Product will be available in 2019. ...
Posted by Michael Wonder on 12 Dec 2018
Mayne Pharma receives FDA approval of Tolsura (SUBA-itraconazole capsules) for the treatment of certain fungal infections
11 December 2018 - Mayne Pharma is pleased to announce that the US FDA has approved the new drug application ...
Posted by Michael Wonder on 10 Dec 2018
Investigation of generic ‘cartel’ expands to 300 drugs
9 December 2018 - Executives at more than a dozen generic drug companies had a form of shorthand to describe ...
Posted by Michael Wonder on 06 Dec 2018
FDA publishes post CRL guidance for generic companies
4 December 2018 - The US FDA has published final guidance for the generics industry on post-complete response letter meetings. ...
Posted by Michael Wonder on 05 Dec 2018
Generic drug prices ‘strongly predictive’ of shortages, study finds
4 December 2018 - How a generic drug is priced may be the difference between whether it experiences a shortage ...
Posted by Michael Wonder on 27 Nov 2018
Perrigo announces tentative FDA approval for the first to file generic version of Ultravate lotion 0.05%
26 November 2018 - Perrigo today announced it has received tentative approval from the U.S. FDA for the first to ...
Posted by Michael Wonder on 10 Nov 2018
FDA highlights record-breaking number of generic drug approvals in October
9 November 2018 - Today, the U.S. FDA is providing a summary of the generic drug approval actions for the ...