Blog
RSS FeedPosted by Michael Wonder on 22 Nov 2018
Allergan announces FDA acceptance of supplemental new drug application for Avycaz (ceftazidime and avibactam)
20 November 2018 - Application seeks to expand the Avycaz label to include treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 29 Oct 2018
TherapeuticsMD announces FDA approval of TX-001HR: Bijuva (oestradiol and progesterone) capsules for the treatment of moderate to severe vasomotor symptoms due to menopause
29 October 2018 - BIJUVA is the first and only FDA approved hormone therapy of bio-identical oestradiol in combination with bio-identical ...
Posted by Michael Wonder on 19 Oct 2018
ViiV Healthcare submits new drug application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
18 October 2018 - Priority review voucher used with submission with anticipated target action date of six months. ...
Posted by Michael Wonder on 13 Oct 2018
FDA approves Stiolto Respimat supplemental new drug application to add data on COPD exacerbation reduction
11 October 2018 - Stiolto Respimat is the first in its class to have exacerbation data in the product labelling. ...
Posted by Michael Wonder on 07 Sep 2018
FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence
7 September 2018 - Agency is taking additional steps to advance the development of new FDA approved treatments for opioid dependence ...
Posted by Michael Wonder on 30 Aug 2018
FDA accepts resubmission of new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
29 August 2018 - Ortho Dermatologics today announced that the U.S. FDA has accepted the resubmitted new drug application for Duobrii ...
Posted by Michael Wonder on 16 Aug 2018
Ortho Dermatologics resubmits U.S. new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
15 August 2018 - Ortho Dermatologics, a division of Bausch Health, today announced it has resubmitted a new drug application to ...
Posted by Michael Wonder on 09 Aug 2018
Glenmark Pharmaceuticals announces FDA acceptance of the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
7 August 2018 - The PDUFA target action date for completion of the FDA review is 21 March 2019. ...
Posted by Michael Wonder on 23 Jul 2018
Aerie Pharmaceuticals announces early notification of FDA acceptance of NDA submission for Roclatan (netarsudil/latanoprost ophthalmic solution)
23 July 2018 - Aerie Pharmaceuticals today reported that it has received the “Day 74” notification from the U.S. FDA earlier ...
Posted by Michael Wonder on 18 Jul 2018
Janssen announces U.S. FDA approval of Symtuza, the first and only complete darunavir-based single tablet regimen for the treatment of HIV-1 infection
17 July 2018 - Once daily, single-tablet regimen delivers the durability and high barrier to drug resistance of darunavir and the ...
Posted by Michael Wonder on 23 Jun 2018
HTX-011 for post-operative pain management receives breakthrough therapy designation from FDA
21 June 2018 - Heron Therapeutics today announced that HTX-011 for post-operative pain management has received breakthrough therapy designation from the ...
Posted by Michael Wonder on 18 Jun 2018
FDA issues complete response letter for Duobrii (halobetasol propionate and tazarotene) lotion
18 June 2018 - Ortho Dermatologics, a division of Valeant Pharmaceuticals, today announced that it has received a complete response ...
Posted by Michael Wonder on 14 Jun 2018
Mylan provides statement on generic Advair Diskus
13 June 2018 - On the afternoon of June 13, 2018, Mylan received an update from the U.S. FDA concerning ...
Posted by Michael Wonder on 21 May 2018
Glenmark Pharmaceuticals announces the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
21 May 2018 - Glenmark Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 16 May 2018
U.S. FDA approves expanded indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for reducing the risk of acquiring HIV-1 in adolescents
15 May 2018 - First agent indicated for uninfected adolescents at risk of acquiring HIV. ...