Blog
RSS FeedPosted 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 14 Jul 2020
Teva announces availability of ProAir Digihaler (salbutamol sulphate 117 mcg) inhalation powder for patients with asthma and COPD
13 July 2020 - First and only digital rescue inhaler with built-in sensors now available by prescription to patients in the ...
Posted by Michael Wonder on 16 Jun 2020
Supreme Court will not hear generic drug price fixing discovery dispute
16 June 2020 - The U.S. Supreme Court on Monday declined to hear generic drug makers’ challenge to a court ...
Posted by Michael Wonder on 25 May 2020
First generic version of Gilead’s remdesivir will be sold by a Bangladesh drug maker
22 May 2020 - A drug maker in Bangladesh has become the first company to sell a generic version of ...
Posted by Michael Wonder on 19 May 2020
CEO tapped by Trump to make generic drugs during pandemic has a dicey track record
19 May 2020 - As the chief executive of Phlow, the new company awarded $354 million by the federal government ...
Posted by Michael Wonder on 18 May 2020
The coronavirus exposed the US' reliance on India for generic drugs. But that supply chain is ultimately controlled by China
17 May 2020 - Sarah Thebarge, a 41-year-old physician assistant living in San Francisco, takes a pill every day to ...
Posted by Michael Wonder on 15 May 2020
A drug company wagers the U.S. won’t dare charge it with crimes
15 May 2020 - Teva, the world’s largest maker of generic drugs, recently pulled out of settlement talks with the Justice ...
Posted by Michael Wonder on 08 May 2020
The pandemic is a chance to revamp India’s pharmaceutical industry
9 May 2020 - Companies could switch from primarily making generics to producing higher-margin licensed drugs. ...
Posted by Michael Wonder on 07 May 2020
Generic drug maker admits to fixing prices for cholesterol medication
7 May 2020 - For conspiring to inflate drug prices, Apotex will pay $24 million and cooperate with the Justice Department’s ...
Posted by Michael Wonder on 25 Apr 2020
Maker of drug touted as coronavirus cure accuses China of gouging
24 April 2020 - Hydroxychloroquine controversially pushed by Trump as COVID-19 remedy. ...
Posted by Michael Wonder on 15 Apr 2020
Product specific guidances for chloroquine phosphate and hydroxychloroquine sulphate
13 April 2020 - The FDA plays a critical role in protecting the United States from threats including emerging infectious ...