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Your search keyword '"Allergan PLC -- Product development"' showing total 24 results
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24 results on '"Allergan PLC -- Product development"'

1. US FDA approves Allergan's NDA for Durysta for ocular hypertension patients

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Hypertension, Patient compliance, Pharmaceutical industry -- Product development, Bimatoprost -- Product development, Open-angle glaucoma, Industrial research, Pharmaceuticals and cosmetics industries
Abstract

Allergan plc, a leading global pharmaceutical company announced that the US Food and Drug Administration (US FDA) has approved the company's New Drug Application (NDA) for Durysta (bimatoprost implant) 10 [...]

Published
2020

2. US FDA accepts Allergan's NDA for Bimatoprost SR for patients with open-angle glaucoma/ocular hypertension

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Hypertension -- Care and treatment, Patient compliance, Pharmaceutical industry -- Product development, Bimatoprost -- Product development, Glaucoma -- Care and treatment, Open-angle glaucoma, Pharmaceuticals and cosmetics industries
Abstract

Allergan plc, a leading global pharmaceutical company with more than 70 years of heritage in eye care, announced that the US FDA has accepted the company's New Drug Application (NDA) [...]

Published
2019

3. US FDA accepts Allergan's NDA for ubrogepant for acute treatment of migraine

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pharmaceutical industry -- Product development, Medical research, Migraine -- Drug therapy, Prescriptions (Drugs) -- Product development, Legal fees, Clinical trials, Pharmaceuticals and cosmetics industries
Abstract

Allergan plc announced that the US Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults. The [...]

Published
2019

4. US FDA accepts NDA to review Seysara for treatment of moderate to severe acne

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Antiacne agents, Acne -- Care and treatment, Pharmaceutical industry -- Product development, Pharmaceuticals and cosmetics industries, Seysara (Medication) -- Product development
Abstract

Allergan plc, a leading global pharmaceutical company, and Paratek Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of therapies based upon tetracycline chemistry, announced that the US Food [...]

Published
2017

5. US FDA accepts Allergan's sNDA filing for Avycaz

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Communicable diseases -- Care and treatment, Pneumonia -- Care and treatment, Pharmaceutical industry -- Product development, Pharmaceuticals and cosmetics industries, Avycaz (Medication)
Abstract

Allergan plc, a leading global pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam) for [...]

Published
2017

6. Allergan's sNDA for avycaz gets US FDA nod to include new phase III data in patients with cUTI, including pyelonephritis

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pyelonephritis -- Care and treatment, Urinary tract infections -- Care and treatment, Pharmaceutical industry -- Product development, Drug approval, Pharmaceuticals and cosmetics industries
Abstract

Allergan plc, a leading global pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to update the label for [...]

Published
2017

7. Study Results from Allergan Plc Update Understanding of Clinical Trials and Studies (Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization In Healthy Adults: Results From a Randomized Trial)

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Clinical trials, Pharmaceutical industry -- Product development, Adults, Genetic research, Genes, Anopheles, Migraine, Editors, Health
Abstract

2020 JAN 6 (NewsRx) -- By a News Reporter-Staff News Editor at Cardiovascular Week -- A new study on Clinical Research - Clinical Trials and Studies is now available. According [...]

Published
2020

8. Allergan submits NDA with the US FDA for ubrogepant to treat migraine

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pharmaceutical industry -- Product development, Medical research, Prescriptions (Drugs) -- Product development, Migraine -- Care and treatment, Clinical trials, Legal fees, Chemistry
Abstract

M2 PHARMA-March 12, 2019-Allergan submits NDA with the US FDA for ubrogepant to treat migraine (C)2019 M2 COMMUNICATIONS Pharmaceutical company Allergan plc (NYSE:AGN) said on Monday that it has successfully [...]

Published
2019

9. Allergan submits NDA with the US FDA for ubrogepant to treat migraine

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pharmaceutical industry -- Product development, Medical research, Prescriptions (Drugs) -- Product development, Migraine -- Care and treatment, Clinical trials, Legal fees, Business
Abstract

M2 EQUITYBITES-March 12, 2019-Allergan submits NDA with the US FDA for ubrogepant to treat migraine (C)2019 M2 COMMUNICATIONS http://www.m2.com Pharmaceutical company Allergan plc (NYSE:AGN) said on Monday that it has [...]

Published
2019

10. FDA Accepts Supplemental New Drug Application (sNDA) Filing for AVYCAZ (ceftazidime and avibactam)

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Hospital patients -- Drug therapy, Communicable diseases -- Drug therapy, Pneumonia -- Drug therapy, Pharmaceutical industry -- Product development, Automobile industry, Avycaz (Medication)
Abstract

Oct. 2 -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for [...]

Published
2017

11. FDA Accepts Supplemental New Drug Application (sNDA) filing for AVYCAZ (ceftazidime and avibactam)

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Bacterial pneumonia -- Drug therapy, Pneumonia -- Drug therapy, Hospital patients -- Drug therapy, Pharmaceutical industry -- Product development, Business, News, opinion and commentary, Avycaz (Medication)
Abstract

- Application Seeks to Expand Label to Include an Indication and Phase 3 Data for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia (HABP/VABP) - DUBLIN, Oct. 2, [...]

Published
2017

12. Allergan, Paratek's acne drug succeeds in two phase 3 trials

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Acne -- Drug therapy, Pharmaceutical industry -- Product development, Antiacne agents, General interest, News, opinion and commentary
Abstract

Calif: Allergan plc has issued the following news release: Allergan and Paratek Pharmaceuticals' acne drug sarecycline has met its primary efficacy endpoints in two phase 3 trials. The studies have [...]

Published
2017

13. Allergan and Paratek Announce Positive Results From Two Phase 3 Trials of Sarecycline for the Treatment of Moderate to Severe Acne

Subjects
United States. Food and Drug Administration, Paratek Pharmaceuticals Inc. -- Product development, Allergan PLC -- Product development, Clinical trials, Acne -- Care and treatment, Antibiotics -- Product development, Pharmaceutical industry -- Product development, Antiacne agents, Business, News, opinion and commentary
Abstract

Program on Track for FDA Submission in the Second Half of 2017 DUBLIN and BOSTON, March 27, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and [...]

Published
2017

14. FDA Approves Allergan's sNDA for AVYCAZ(r) (ceftazidime and avibactam) to include new Phase III data in Patients with Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pyelonephritis, Urinary tract infections, Pharmaceutical industry -- Product development, Drug approval, General interest, News, opinion and commentary, Avycaz (Medication)
Abstract

DUBLIN: Allergan plc has issued the following news release: Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the [...]

Published
2017

15. Ireland : FDA approves Allergan's sNDA for AVYCAZ (ceftazidime and avibactam) to include new Phase III data in Patients with Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pyelonephritis, Urinary tract infections, Pharmaceutical industry -- Product development, Drug approval, Business, international, Avycaz (Medication)
Abstract

Allergan plc, a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to update the label for [...]

Published
2017

16. FDA Approves Allergan's sNDA for AVYCAZ (ceftazidime and avibactam) to include new Phase III data in Patients with Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pyelonephritis, Urinary tract infections, Pharmaceutical industry -- Product development, Drug approval, General interest, News, opinion and commentary, Avycaz (Medication)
Abstract

Allergan plc.: Allergan plc. has issued the following press release: Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved [...]

Published
2017

17. FDA Approves Allergan's sNDA for AVYCAZe (ceftazidime and avibactam) to include new Phase III data in Patients with Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pyelonephritis, Urinary tract infections, Pharmaceutical industry -- Product development, Drug approval, Business, News, opinion and commentary, Avycaz (Medication)
Abstract

- New clinical data for AVYCAZ demonstrates efficacy in cUTI patients including those with infections due to resistant Gram-negative pathogens - - Responding to the urgent public health threat posed [...]

Published
2017

18. Ironwood and Allergan Report Topline Phase IIb Data Supporting Further Investigation of Linaclotide Colonic Release-2 (CR2) for Abdominal Pain in Non-Constipation Subtypes of IBS

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Clinical trials, Constipation, Pharmaceutical industry -- Product development, Business, Business, international
Abstract

Data also support potential for broad opportunity to treat additional GI indications associated with abdominal pain Companies separately announced Phase IIb data with linaclotide colonic release-1 (CR1) for IBS-C Ironwood [...]

Published
2016

19. United States : USFDA approves Allergan's NDA filing for Oxymetazoline HCI cream 1.0%

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Pharmaceutical industry -- Product development, Drug approval, Business, international
Abstract

Allergan plc has announced that the U.S. Food and Drug Administration (FDA) has approved for standard review the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational [...]

Published
2016

20. Ironwood Reports Positive Top-Line Results from Phase III Trial of 72 mcg Linaclotide in Adults with Chronic Idiopathic Constipation

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Clinical trials, Constipation -- Drug therapy, Pharmaceutical industry -- Product development, Business, Business, international, Linzess (Medication)
Abstract

CAMBRIDGE, Mass. -- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the Phase III clinical trial of its 72 mcg dose of linaclotide in adults with chronic idiopathic constipation (CIC) [...]

Published
2015

21. Positive Phase III results demonstrate efficacy of antibiotic medicine CAZ-AVI in complicated Urinary Tract Infections

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, AstraZeneca PLC -- Product development, Bacterial infections -- Care and treatment -- Health aspects, Urinary tract infections -- Care and treatment -- Health aspects, Antibiotics -- Product development -- Health aspects, Pharmaceutical industry -- Product development -- Health aspects, General interest, News, opinion and commentary
Abstract

Sep 02, 2015 (M2 PRESSWIRE via COMTEX) -- AstraZeneca today announced positive topline results from RECAPTURE 1 and RECAPTURE 2, the pivotal Phase III studies evaluating the antibiotic, CAZ-AVI (ceftazidime-avibactam), [...]

Published
2015

22. Positive Phase III Results Demonstrate Efficacy Of Antibiotic Medicine AVYCAZ(TM) (ceftazidime-avibactam) In Complicated Urinary Tract Infections

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, AstraZeneca PLC -- Product development, Bacterial infections -- Drug therapy, Urinary tract infections -- Drug therapy, Antibiotics -- Product development, Pharmaceutical industry -- Product development, Ceftazidime -- Product development, Business, News, opinion and commentary, Avycaz (Medication)
Abstract

DUBLIN, Sept. 2, 2015 /PRNewswire/ -- (NYSE: AGN) Allergan plc. today announced positive topline results from RECAPTURE 1 and 2, the pivotal Phase III studies evaluating the antibiotic AVYCAZ(TM) (ceftazidime-avibactam) [...]

Published
2015

23. Positive Phase III results demonstrate efficacy of antibiotic medicine CAZ-AVI in complicated Urinary Tract Infections

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, AstraZeneca PLC -- Product development, Bacterial infections -- Care and treatment -- Health aspects, Urinary tract infections -- Care and treatment -- Health aspects, Antibiotics -- Product development -- Health aspects, Pharmaceutical industry -- Product development -- Health aspects, Business, Business, international
Abstract

M2 PRESSWIRE-September 2, 2015-: Positive Phase III results demonstrate efficacy of antibiotic medicine CAZ-AVI in complicated Urinary Tract Infections (C)1994-2015 M2 COMMUNICATIONS RDATE:02092015 AstraZeneca today announced positive topline results from [...]

Published
2015

24. FDA Approves Actavis' Abbreviated NDA for Exalgo Tablets - Shares Firm Late

Subjects
United States. Food and Drug Administration, Allergan PLC -- Product development, Mallinckrodt Inc. -- Product development, Medical test kit industry -- Product development, Medical equipment and supplies industry -- Product development, Drug approval, Pharmaceutical industry -- Product development, Business, Exalgo (Medication) -- Product development
Abstract

Boston, May 13, 2014 (MidnightTrader via COMTEX) -- Actavis plc (ACT) has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a [...]

Published
2014

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