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FDA consent decree with Ascend Labs backed by federal judge

FDA consent decree with Ascend Labs backed by federal judge

15-10-2014

A federal judge from the US District Court for the Southern District of Ohio entered a consent decree…

Ascend LaboratoriesGenericsLegalProductionRegulationUSA

Hospira warned by FDA over Australian manufacturing facility

Hospira warned by FDA over Australian manufacturing facility

02-10-2014

USA-based injectable generic drugs specialist Hospira revealed in a filing with the US Securities and…

AustraliaGenericsHospiraProductionRegulationUSA

Indian government takes action over dubious fixed-dose combinations

Indian government takes action over dubious fixed-dose combinations

30-09-2014

In a bid to weed out potentially unsafe combinations, the Central Drugs Standards and Control Organization…

Cadila PharmaGenericsIndiaPricingRegulation

Update: Negotiations on EU-Canada Free Trade Agreement concluded

Update: Negotiations on EU-Canada Free Trade Agreement concluded

29-09-2014

Canadian trade group Research-Based Pharmaceutical Companies (Rx&D) expressed its support to the government…

CanadaEuropeGenericsMarkets & MarketingPatentsPoliticsRegulation

Actavis files ANDA for generic of Purdue's Butrans

Actavis files ANDA for generic of Purdue's Butrans

26-09-2014

Ireland-headquartered generics major Actavis has filed an Abbreviated New Drug Application with the US…

ActavisAnalgesiaBuprenorphineButransGenericsLegalPurdue PharmaRegulationUSA

Bill to increase competition for generic drugs introduced in USA

Bill to increase competition for generic drugs introduced in USA

19-09-2014

US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined…

GenericsLegalPoliticsRegulationUSA

GPhA calls for feedback and dialogue on US generic legislation

GPhA calls for feedback and dialogue on US generic legislation

18-09-2014

The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User…

GenericsGPhALegalRegulationUSA

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

02-09-2014

UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory…

EuropeEvohalerFinancialFluticasone PropionateGenericsGlaxoSmithKlineMylanProsonixRegulationRespiratory and Pulmonary

Australia participating in EU DCP for evaluation of generic drugs

Australia participating in EU DCP for evaluation of generic drugs

02-09-2014

Under the auspices of the International Generic Drug Regulators Pilot , Australia’s Therapeutic Goods…

AustraliaGenericsRegulation

Actavis confirms patent challenge for generic Neupro

Actavis confirms patent challenge for generic Neupro

23-08-2014

Ireland-headquartered generics major Actavis on Friday confirmed that it has filed an Abbreviated New…

ActavisGenericsLegalNeuproNeurologicalPatentsRegulationUCBUSA

Europe to boost cooperation with international partners on generics

Europe to boost cooperation with international partners on generics

08-08-2014

The European Union’s decentralized procedure is being used as a model to accelerate the assessment…

EuropeEuropean UnionGenericsGlobalRegulation

US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

FDA accepts Teva’s NDA for albuterol MDPI

FDA accepts Teva’s NDA for albuterol MDPI

15-07-2014

Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration…

albuterolExercise-induced bronchospasmGenericsPulmonologyRegulationRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

US regulatory warnings on drug producers extend well beyond India

US regulatory warnings on drug producers extend well beyond India

14-07-2014

Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical…

CiplaDr Reddy's LaboratoriesGenericsIndiaLupinProductionRanbaxy LaboratoriesRegulationSun PharmaceuticalUSA

Actavis confirms patent challenge to Duchesnay’s Diclegis

Actavis confirms patent challenge to Duchesnay’s Diclegis

12-07-2014

Ireland-based generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application…

ActavisDiclegisDuchesnayGenericsPatentsRegulationUSAWomen's Health

Mylan launches generic Micardis in USA

Mylan launches generic Micardis in USA

08-07-2014

US generic drugmaker Mylan has launched Telmisartan Tablets USP, 20mg, 40mg and 80mg, the generic version…

Boehringer IngelheimCardio-vascularGenericsMarkets & MarketingMicardisMylanRegulationTelmisartanUSA

South Africa regulator gives MSF access to cheaper TB drug linezolid

South Africa regulator gives MSF access to cheaper TB drug linezolid

01-07-2014

After a three-year long struggle, humanitarian aid agency Medecins Sans Frontieres has received approval…

Antibiotics and Infectious diseasesGenericsHealthcareLinezolidPfizerRegulationSouth AfricaZyvox

Actavis and Forest to divest four generics to gain FTC OK for merger

01-07-2014

In order for Ireland-headquartered generics major Actavis to complete its previously-announced $25 billion…

ActavisForest LaboratoriesGeneric pharmaceuticalsGenericsHealth Medical PharmaMedicinePharmaceutical industryPharmacologyRegulationUSA

Russian government plans to cut number of generics; controls on MNCs

Russian government plans to cut number of generics; controls on MNCs

23-06-2014

The number of drugs in the Russian market will decline significantly over the next several years, due…

GenericsPricingRegulationRussia

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