Blog
RSS FeedPosted by Michael Wonder on 18 Oct 2018
Advancing toward the goal of global approval for generic drugs: FDA proposes critical first steps to harmonise the global scientific and technical standards for generic drugs
18 October 2018 - Too many Americans struggle with the high cost of drugs. In some cases, patients go without ...
Posted by Michael Wonder on 11 Oct 2018
FDA again approves record-breaking number of generic drugs
11 October 2018 - The FDA approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ...
Posted by Michael Wonder on 09 Oct 2018
Statement from FDA Commissioner on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
9 October 2018 - As part of the U.S. FDA’s efforts to promote drug competition and patient access, we’ve advanced ...
Posted by Michael Wonder on 02 Oct 2018
Statement from FDA Commissioner on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
2 October 2018 - When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the ...
Posted by Michael Wonder on 27 Sep 2018
A perspective from our CEO: Gilead subsidiary to launch authorised generics to treat HCV
24 September 2018 - Today, Gilead announced a plan to introduce a generic version of our leading cures for hepatitis ...
Posted by Michael Wonder on 24 Sep 2018
Gilead subsidiary to launch authorised generics of Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C
24 September 2018 - List price of authorised generics to reflect discounts in the system today. ...
Posted by Michael Wonder on 20 Sep 2018
Generics would hit the market faster under Senate bill, saving more than 3 billion dollars, says CBO
19 September 2018 - Lower-price drugs would hit the market faster under a bipartisan bill awaiting a vote in the ...
Posted by Michael Wonder on 20 Sep 2018
ACCC approves local merger of pharma firms Arrow and Apotex
20 September 2018 - Half of all generic prescriptions could come from one supplier after the competition watchdog approved a ...
Posted by Michael Wonder on 17 Sep 2018
Sun Pharma and SPARC announce US FDA approval of Xelpros to treat open-angle glaucoma or ocular hypertension
14 September 2018 - Xelpros (latanoprost ophthalmic emulsion) 0.005% for topical ophthalmic use is the first and only benzalkonium chloride-free (BAK-free) ...
Posted by Michael Wonder on 13 Sep 2018
FDA issues 54 product-specific guidances to promote generic drug access and drug price competition
13 September 2018 - The U.S. FDA today announced a new set of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 21 Aug 2018
United States FDA approves Teva's generic epinephrine injection auto-injector
16 August 2018 - Teva is pleased with the US FDA's approval of its generic versions of EpiPen and EpiPen ...
Posted by Michael Wonder on 17 Aug 2018
FDA approves generic EpiPen that may be cheaper
16 August 2018 - The FDA on Thursday approved the first generic version of EpiPen, providing new competition that could ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves first generic version of EpiPen
16 August 2018 - The U.S. FDA today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for ...
Posted by Michael Wonder on 08 Aug 2018
FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
8 August 2018 - The U.S. FDA today approved several strengths of potassium chloride oral solution as the first generic drugs ...
Posted by Michael Wonder on 02 Aug 2018
Acrux submits first-to-file application for generic version of Jublia making it eligible for 180 days of generic exclusivity
2 August 2018 - Acrux is pleased to announce that the US FDA has accepted for review the Paragraph IV Abbreviated ...