Generics/News

Impax launches new high-strength ADHD generics

Generics/News | Posted 11/08/2017

Impax Laboratories Inc (Impax) has received US Food and Drug Administration (FDA) approval for additional strength capsules of generic Focalin XR (dexmethylphenidate hydrochloride), which was originally marketed by Novartis and is used to treat attention deficit hyperactivity disorder (ADHD).

FDA approval for generics of ADHD drug Strattera

Generics/News | Posted 23/06/2017

The US Food and Drug Administration announced on 30 May 2017 the approval of the first generic versions of Strattera (atomoxetine).

FDA approves two new Seroquel XR generics

Generics/News | Posted 16/06/2017

The US Food and Drug Administration (FDA) has approved two generic versions of Astra Zeneca’s antidepressant Seroquel XR, which has a billion-dollar market in the US.

Vytorin generic launched in the US

Generics/News | Posted 26/05/2017

The US Food and Drug Administration (FDA) has approved a generic version of the anti-cholesterol drug Vytorin, which will be launched on the US market by Impax Laboratories Inc (Impax).

First Advair generic launched in the US

Generics/News | Posted 05/05/2017

Teva Pharmaceutical Industries (Teva) has announced the launch of AirDuo RespiClick and its authorized generic, the first competitor to GlaxoSmithKline's (GSK) best-selling asthma drug Advair in the US.

Patent challenges hit Actavis and Acorda

Generics/News | Posted 28/04/2017

Teva Pharmaceuticals’ subsidiary Actavis and neurological drug specialist Acorda Therapeutics have both faced patent challenges recently over treatments for acne and multiple sclerosis, respectively.

FDA approves Akorn’s mycophenolate mofetil following Form 483 resolution

Generics/News | Posted 07/04/2017

US-based generic pharmaceutical manufacturer, Akorn Inc has announced that its sterile manufacturing site in Decatur, Illinois, USA has received a No Action Indicated (NAI) status from the US Food and Drug Administration (FDA). This is following the sites re-inspection in December 2016.

Generic antidepressant launched in the US

Generics/News | Posted 31/03/2017

US pharma giant Pfizer is facing competition for its antidepressant Pristiq (desvenlafaxine) with generics hitting the market in the US.

FDA approves rare disease deflazacort at exorbitant price

Generics/News | Posted 17/03/2017

Deflazacort is a steroid treatment that has long been approved in many countries outside the US. In February 2016, the US Food and Drug Administration (FDA) approved Marathon Pharmaceuticals’ deflazacort (Emflaza) for the treatment of Duchenne muscular dystrophy. However, it is reported that the drug will come with a devastating price-tag of US$89,000 a year, far more than prices charged abroad.

Generic lung cancer treatment now available in China

Generics/News | Posted 10/03/2017

A generic version of AstraZeneca’s Iressa (gefitinib) has been released onto the market in China. This generic drug is being marketed under the brand name Yiruike and is produced by Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu).

US approves generic of narcolepsy drug Xyrem

Generics/News | Posted 24/02/2017

The US Food and Drug Administration (FDA) has approved the first generic version of Xyrem (sodium oxybate) – the only drug approved to treat the sudden muscle weakness seen in narcolepsy.

Endo launches generic version of Zetia

Generics/News | Posted 27/01/2017

Ireland-based Endo International plc has announced that its operating company Par Pharmaceutical will ship the first generic version of Merck & Co’s blockbuster cholesterol medication Zetia.

Natco Pharma and Alvogen launch first US Tamiflu generic

Generics/News | Posted 20/01/2017

Natco Pharma (Natco) and their marketing partner Alvogen have launched the first generic equivalent of Roche’s flu treatment Tamiflu (oseltamivir phosphate) in the US.

Mylan launches generic EpiPen

Generics/News | Posted 13/01/2017

US-based drugmaker Mylan announced on 16 December 2016 that it had launched the authorized generic version of its EpiPen (epinephrine) injectors at a wholesale price of US$300 per two-pack. This price, the company says, ‘is more than 50% lower’ than the brand-name price.

Lupin and Natco’s Armodafinil generic approved to treat sleep disorders by FDA

Generics/News | Posted 06/01/2017

The US subsidiary of Indian drug manufacturer, Lupin Pharmaceuticals, announced on 29 November 2016 that its Armodafinil tablets had received approval from the US Food and Drug Administration (FDA). Marketing and promotion of the product in the US will begin shortly.

Mylan to make generic hepatitis drug under MPP sublicence

Generics/News | Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) announced on 28 November 2016 that the company had signed a sublicence with the Medicines Patent Pool (MPP) to make a generic of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

Dr Reddy’s makes deal with Gland Pharma for US injectables

Generics/News | Posted 18/11/2016

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 October 2016 that it had entered into a ‘strategic collaboration’ with India-based sterile dosage form maker Gland Pharma.

Teva sells Actavis’ UK and Ireland generics business to Intas

Generics/News | Posted 28/10/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 5 October 2016 that it had agreed to sell the UK and Ireland generics business of Actavis to Accord Healthcare (a subsidiary of Intas Pharmaceuticals) for GBP 603 million, subject to final approval from the European Commission (EC).

Mylan agrees to pay fine over EpiPen rebates

Generics/News | Posted 21/10/2016

US-based drugmaker Mylan announced on 7 October 2016 that it had agreed to pay US$465 million to the US Department of Justice (DOJ) and other government agencies. The agreement, the company says, will resolve questions that have been raised about the classification of its EpiPen injectors for the Medicaid Drug Rebate Program. The deal has also been made without the company having to admit any wrongdoing.

Teva recalls antibiotic and anti-seizure drug

Generics/News | Posted 30/09/2016

Recent US Food and Drug Administration (FDA) reports have caused Israeli generics producer Teva Pharmaceutical Industries (Teva) to recall a treatment for seizures, as well as an antibiotic made at its sterile manufacturing plant in Hungary.

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