Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2017
Mylan announces U.S. FDA approval of first generic for Copaxone 40 mg/mL 3-times-a-week and may be eligible for 180-day exclusivity
3 October 2017 - Mylan also receives U.S. FDA approval of generic for Copaxone 20 mg/mL once daily. ...
Posted by Michael Wonder on 02 Oct 2017
Reducing the hurdles for complex generic drug development
2 October 2017 - Earlier this year, I announced our Drug Competition Action Plan to advance new policies aimed at bringing ...
Posted by Michael Wonder on 24 Sep 2017
Generics industry calls FDA draft guidance on priority reviews 'basically inoperable'
22 September 2017 - A generic drug industry group and several companies have taken issue with recent US FDA draft ...
Posted by Michael Wonder on 18 Sep 2017
Strategies that delay market entry of generic drugs
18 September 2017 - Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although ...
Posted by Michael Wonder on 07 Aug 2017
Teva announces FDA approval of Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol
7 August 2017 - Maintenance treatment option designed to eliminate the need for hand-breath co-ordination during inhalation. ...
Posted by Michael Wonder on 07 Aug 2017
Take the generic, patients are told. Until they are not.
6 August 2017 - It’s standard advice for consumers: if you are prescribed a medicine, always ask if there is ...
Posted by Michael Wonder on 06 Aug 2017
FDA’S generic drug labelling rule delayed again
4 August 2017 - The FDA won’t be issuing a controversial final rule on label changes concerning generic drug safety ...
Posted by Michael Wonder on 20 Jul 2017
FDA may publicly shame drug makers for thwarting generic rivals
19 July 2017 - Attention brand-name drug makers: the FDA may soon publicly shame you for thwarting generic rivals. ...
Posted by Michael Wonder on 11 Jul 2017
FDA speeding generic drug approvals: not just lip service
10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began ...
Posted by Michael Wonder on 28 Jun 2017
FDA commissioner takes on Martin Shkreli-wannabes over huge drug price hikes
28 June 2017 - "We don't play a role in drug pricing, but we do affect drug competition," Dr. Scott Gottlieb ...
Posted by Michael Wonder on 27 Jun 2017
FDA tackles drug competition to improve patient access
27 June 2017 - Agency takes important steps under new Drug Competition Action Plan. ...
Posted by Michael Wonder on 21 Jun 2017
FDA working to lift barriers to generic drug competition
21 June 2017 - Too many patients are being priced out of the medicines they need. ...
Posted by Michael Wonder on 20 Jun 2017
Priority generic drug reviews: new FDA draft guidance
19 June 2017 - In preparation of its commitments under the second Generic Drug User Fee Amendments, the US FDA ...
Posted by Michael Wonder on 17 Jun 2017
Adamis wins U.S. approval to sell EpiPen rival, shares soar
15 June 2017 - Adamis Pharmaceuticals said on Thursday it received U.S. approval for its emergency epinephrine syringes to treat ...
Posted by Michael Wonder on 15 Jun 2017
FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus
15 June 2017 - Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference ...