Navigation Links
Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
Date:5/22/2012

ALLEGAN, Mich., May 22, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole·1®. Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity. Perrigo is working exclusively with KV Pharmaceutical Company on a collaboration to launch the product by the end of calendar year 2012.

(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO )

Gynazole·1® (butoconazole nitrate) vaginal cream, 2%, is indicated for the local treatment of vulvovaginal candidiasis (infections cause by Candida). Prior to the voluntary discontinuation of the product in January 2009 due to manufacturing issues at KV Pharmaceutical, Gynazole·1® annual sales were approximately $28 million, as measured by Wolters Kluwer Health.

Perrigo's Chairman, President and Chief Executive Officer, Joseph C. Papa, stated, "This approval once again exemplifies how our robust research and development abilities in the areas of creams, foams, gels and liquids translate into new product approvals. Perrigo is committed to making quality healthcare more accessible and affordable for our customers."

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company's primary markets and locations of manufacturing and logistics operatio
'/>"/>

SOURCE Perrigo Company
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules
2. Perrigo Company to Present at the Bank of America Merrill Lynch 2012 Healthcare Conference
3. Perrigo Reports Record Third Quarter Revenue And Earnings And Raises Full Year EPS Guidance
4. Perrigo Company Will Release Third Quarter Fiscal 2012 Results On May 8, 2012
5. Perrigo Company to Present at the RBC Capital Markets Healthcare Conference
6. Perrigo Announces the Launch of Loratadine-D 12 Store Brand Labels -- the First Store Brand Launch That Compares to Claritin-D® 12
7. Perrigo Company to Present at the Leerink Swann 2012 Global Healthcare Conference
8. Perrigo Company Announces Quarterly Dividend
9. Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray and Announcement of Patent Infringement Lawsuit by Meda Pharmaceuticals
10. Perrigo Wins Summary Judgment in Generic Mucinex® Case
11. Perrigo Acquires Assets of CanAm Care for $36 Million
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... PARIS , July 30, 2014 /PRNewswire/ ... Sanofi (EURONEXT: SAN and NYSE: SNY ) ... of alirocumab in people with hypercholesterolemia met their primary ... in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared ... monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). ...
(Date:7/30/2014)... 2014  DigiPath, Inc. (OTCBB and OTCQB: DIGP), a ... cannabis testing and education markets, announced today that has ... not previously disclosed or, to its knowledge, any other ... "We have noticed unusual price and volume ... days," said Steve Barbee , CEO of DigiPath. ...
(Date:7/30/2014)... Coordinators, Inc. (PCI) is pleased to announce it has ... Limited (Penn Pharma). Penn Pharma is headquartered in Tredegar, ... Kingdom and operates regional offices in ... Tokyo , Japan. Penn Pharma offers both drug development ... manufacturing, as well as Clinical Packaging, Labeling, and global ...
Breaking Medicine Technology:Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 2Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 4Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 5Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 6Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 7Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 8DigiPath No New Corporate Developments 2PCI Announces Definitive Agreement to Acquire Penn Pharma 2PCI Announces Definitive Agreement to Acquire Penn Pharma 3PCI Announces Definitive Agreement to Acquire Penn Pharma 4PCI Announces Definitive Agreement to Acquire Penn Pharma 5
... FDA approved Makena (hydroxyprogesterone caproate) in February 2011 ... births in women who have had at least one ... approved, a version of the active ingredient of Makena ... drug from a pharmacist who compounded the drug.  In ...
... N.J., Nov. 8, 2011 Covance Inc. (NYSE: ... Credit Suisse Healthcare Conference on Thursday, November 10, 2011 at ... the presentation at www.covance.com .  In order to register ... early. Covance, with headquarters in Princeton, New Jersey, ...
Cached Medicine Technology:FDA Statement on Makena 2Covance to Present at Credit Suisse 2011 Healthcare Conference 2
(Date:7/30/2014)... (HealthDay News) -- Clues to whether a person is at ... a new study suggests. Chemical changes to a gene ... spur suicidal thoughts and behaviors, the study,s authors explained. Spotting ... to a patient,s risk for suicide, they said. "Suicide ... been stymied in our prevention efforts because we have no ...
(Date:7/30/2014)... digital pathology market was valued at an estimated $250.2 million ... of 11.8%, to reach an estimated $437 million by 2018. ... expected to continue to rise in the coming years as ... pathologists to be efficient and this leads to improved quality ... was valued at $128.9 million and accounted for the largest ...
(Date:7/30/2014)... news release is available in French . ... led by Claude Gronfier (Inserm Unit 846: Stem Cell ... a study under real conditions on the body clocks ... The researchers have shown that a particular kind of ... rhythms are correctly synchronised despite the absence of sunlight. ...
(Date:7/30/2014)... with depression as preschoolers are likely to suffer from ... shows. , Depressed preschoolers were 2.5 times more likely ... school than kids who were not depressed at very ... of Medicine in St. Louis. , Their study is ... Journal of Psychiatry . , "It,s the same old ...
(Date:7/30/2014)... have found that a support program administered entirely ... symptoms in informal caregivers, such as family or ... published online in advance of print in the ... caring for people with Alzheimer,s disease or other ... deal of pressure," said principal investigator Geoffrey Tremont, ...
Breaking Medicine News(10 mins):Health News:Could a Blood Test Predict Suicide Risk? 2Health News:Could a Blood Test Predict Suicide Risk? 3Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 2Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 3Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 4Health News:Global Digital Pathology Market To See 11.8% CAGR to 2018 Says a New Research Report Available at ReportsnReports.com 5Health News:Dimly lit working environments: Correcting your body clock is possible! 2Health News:Dimly lit working environments: Correcting your body clock is possible! 3Health News:Dimly lit working environments: Correcting your body clock is possible! 4Health News:Many depressed preschoolers still suffer in later school years 2Health News:Many depressed preschoolers still suffer in later school years 3Health News:Study: Telephone support program beneficial for caregivers of those with dementia 2
... E-coli 0157, which is a stark eye-opener that adequate measures ... fatal food poisoning infection//. Three fresh cases, not connected to ... in South Lanarkshire, were confirmed yesterday. , ,A warning ... its dangers. But this by no means is to instigate ...
... at an IVF clinic almost destroyed their lives. In an interview ... they had to undergo when they came to know that the ... ,The couple had twins and it was quite obvious that ... by Leeds NHS Trust. "I was physically sick. The thought that ...
... says, as smoking, eating poor diets like too little fish, fruit and vegetables puts human ... ... ,Insufficient consumption of ... European Food Safety Authority, Netherland says. ,Dutch National Institute for Public Health and ...
... of exercise results from an increase in a protein ... and cause cell death. ,A study reports ... inhibits the action of another protein called insulin-like growth ... due to which the result appears. ,In ...
... people have died of heat and hundreds of people suffering ... Punjab province// , Daily Times newspaper reported Monday. ,At ... said. ,Most of the deaths were reported from ... in Multan and 48 degrees in Dera Ghazi Khan and ...
... Gurgaon (Haryana). When millions of disabled people are still dreaming ... has etched out// her own identity as a voice and ... the blind community faces a lot of barriers ranging from ... to be different can help them to overcome all of ...
Cached Medicine News:Health News:Unhealthy Diet Reduces Life Expectancy 2Health News:'Being Disabled Is Not a Barrier to Success' 2
The Guidant Fineline II Sterox Atrial J is a steroid-eluting pacing lead designed for permanent implantation for either atrial or ventricular applications....
The Guidant Fineline II Sterox is a steroid-eluting pacing lead designed for permanent implantation for either atrial or ventricular applications....
The Guidant Fineline II Sterox is a steroid-eluting pacing lead designed for permanent implantation for either atrial or ventricular applications....
Steroid eluting pacemaker leads...
Medicine Products: