Pharma News - Drug/Product Approvals News & Articles

521 Vilazodone for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant what is the number needed to treat, number needed to harm and likelihood to be helped or harmed International Journal of Clinical Practice, March 19, 2012    Evidence Based Medicine    Clinical Article

522 U.S. FDA approves natazia as the first combined oral contraceptive to treat heavy menstrual bleeding (hmb) Full Text BayNews International, March 16, 2012

523 FDA approves 2 pancreatic enzyme products to aid food digestion Full Text Drug Topics, March 15, 2012

524 FDA approves first 4-strain flu vaccine Full Text Drug Topics, March 15, 2012

525 Watson confirms bystolic patent challenge Full Text Actavis, March 15, 2012

526 Proposed FDA approval pathway could increase pharmacists role with OTCs Full Text American Pharmacists Association News, March 14, 2012

527 Roche receives request for additional information from the Federal Trade Commission Full Text Roche, March 14, 2012

528 AstraZeneca files lawsuit against the FDA for decision regarding quetiapine product labeling and exclusivity Full Text AstraZeneca, March 14, 2012

529 FDA Commissioner Testifies for PDUFA Reauthorization Full Text Pharmaceutical Technology, March 14, 2012

530 FDA Releases Draft Guidance on Monitoring Crude Heparin for Quality Full Text Pharmaceutical Technology, March 12, 2012

531 FDA responds to astrazeneca citizen petitions on quetiapine product labeling Full Text AstraZeneca, March 12, 2012

532 Eylea (aflibercept) injection approved for the treatment of wet age-related macular degeneration in australia Full Text BayNews International, March 9, 2012

533 Abbotts new freestyle insulinx blood glucose monitoring system receives FDA clearance Abbott, March 9, 2012

534 Covidien revascularization device receives FDA clearance Covidien, March 9, 2012

535 First medication approved by FDA for patients with endogenous Cushings syndrome Full Text Drug Topics, March 8, 2012

536 Abbott's absolute pro vascular self-expanding stent system receives FDA approval for treatment of iliac artery disease Abbott, March 8, 2012

537 Covidien peripheral vascular stent system receives FDA approval Covidien, March 8, 2012

538 Zolpidem tartrate (Intermezzo): First insomnia therapy for middle-of-the-night waking followed by difficulty returning to sleep Full Text Formulary , March 7, 2012

539 Covidien revascularization device receives FDA clearance Covidien, March 7, 2012

540 FDA approves preservative-free solution for glaucoma, ocular hypertension Full Text Drug Topics, March 6, 2012

1 U.S. FDA Approves INVOKANA (Canagliflozin) to Treat Adults with Type 2 Diabetes Janssen, April 1, 2013    Free full text

2 Daratumumab Granted Fast Track Designation from US Food and Drug Administration Genmab, April 3, 2013    Free full text

3 FDA approves treatment for postmenopausal women experiencing pain during intercourse Drug Topics, March 7, 2013    Free full text

4 FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs BioPharm International, April 18, 2013    Free full text

5 Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL (posaconazole) Merck, April 11, 2013    Free full text

6 CryoLife Receives FDA Clearance For Next Generation HeRO Device CryoLife, April 5, 2013    Free full text

7 Warner Chilcott Announces FDA Approval of New Oral Contraceptive Warner Chilcott, April 25, 2013    Free full text

8 Ospemifene: New treatment for postmenopausal women American Pharmacists Association News, April 5, 2013    Free full text

9 Bayer's Stivarga (regorafenib) Tablets Approved in Japan Onyx Pharmaceuticals, March 26, 2013    Free full text

10 Takeda and Millennium Announce Approval of ADCETRIS (Brentuximab Vedotin) in Switzerland Millennium Pharmaceuticals, April 8, 2013    Free full text

11 FDA approves Diclegis for pregnant women experiencing nausea and vomiting FDA Press Announcements, April 12, 2013    Free full text

12 FDA approves new multiple sclerosis treatment: Tecfidera FDA Press Announcements, April 1, 2013    Free full text

13 FDA approves once-monthly aripiprazole for schizophrenia Drug Topics, March 14, 2013    Free full text

14 Taro Receives FDA Approval For Topicort (desoximetasone) Topical Spray, 0.25% Taro Pharmaceuticals USA, April 15, 2013    Free full text

15 FDA Advisory Committee recommends approval of BREO ELLIPT for the treatment of COPD GlaxoSmithKline, April 19, 2013    Free full text

16 Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C Gilead, April 9, 2013    Free full text

17 FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes FDA Press Announcements, March 25, 2013    Free full text

18 FDA Approves New Drug Application (NDA) for Tevas Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy Teva Pharmaceutical Industries, April 10, 2013    Free full text

19 FDA approves Invokana to treat type 2 diabetes FDA Press Announcements, April 1, 2013    Free full text

20 Sarepta Therapeutics Announces FDA Will Consider Accelerated Approval for Eteplirsen After Further Review of Data on Dystrophin and Clinical Outcomes Sarepta Therapeutics, April 19, 2013    Free full text