Generics/News

FDA approval for guaifenesin generics

Generics/News | Posted 02/10/2015

Allergan (formerly Actavis) and its partner Perrigo Company (Perrigo) announced on 10 September 2015 that the companies had received US Food and Drug Administration (FDA) approval for their abbreviated new drug applications for three guaifenesin generics.

First generic version of Alzheimer’s patch launched in US

Generics/News | Posted 25/09/2015

US generics company Alvogen announced on 31 August 2015 the launch of its generic equivalent of Novartis’s Alzheimer’s disease treatment Exelon patch (rivastigmine transdermal system) in the US.

Mylan sued over generic prostate cancer drug

Generics/News | Posted 18/09/2015

Generics giant Mylan announced on 18 August 2015 that the company was being sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen Research & Development in connection with the filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for generic abiraterone acetate.

Advocates demand generic version of Abbott’s HIV drug Kaletra

Generics/News | Posted 09/12/2011

FDA watchdog Public Citizen, along with public health groups in a dozen countries, has launched a global campaign demanding the authorisation of generics competition for Abbott Laboratories’ HIV drug Kaletra (lopinavir/ritonavir) before its exclusivity expires.

Yasmin generic launched in US

Generics/News | Posted 11/09/2015

US generics giant Mylan Pharmaceuticals (Mylan) announced on 8 September 2015 the US launch of its generic version of Bayer’s oral contraceptive pill Yasmin (drospirenone/ethinyl estradiol), following approval by the US Food and Drug Administration (FDA) of its abbreviated new drug applications (ANDA). This marks Mylan’s thirteenth oral contraceptive launch in the US.

US FDA approval for Hep B and osteoporosis generics

Generics/News | Posted 04/09/2015

Indian generics maker Aurobindo Pharma (Aurobindo) has received US Food and Drug Administration (FDA) approval for two more generics from its portfolio, bringing its total abbreviated new drug application (ANDA) approvals to 210 (182 final and 28 tentative).

Alzheimer generic launched in the US

Generics/News | Posted 28/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 13 July 2015 the launch of generic memantine hydrochloride tablets in dosages of 5 and 10 mg, following approval of the company’s abbreviated new drug application (ANDA) by the US Food and Drug Administration (FDA).

Generic Parkinson’s drug hits US market

Generics/News | Posted 21/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 12 August 2015 that it had launched generic pramipexole dihydrochloride extended-release tablets in dosages of 0.375, 0.75, 1.5, 3 and 4.5 mg, following approval of the company’s abbreviated new drug application by the US Food and Drug Administration on 7 August 2015.

ANI Pharmaceuticals acquires 22 generics from Teva

Generics/News | Posted 14/08/2015

US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 13 July 2015 that it had acquired 22 previously marketed generics from Teva Pharmaceutical Industries (Teva).

Generic bivalirudin approved in US

Generics/News | Posted 07/08/2015

US-based injectables and biosimilars specialist Hospira announced on 16 July 2015 the approval of its abbreviated new drug application (ANDA) for generic bivalirudin for injection by the US Food and Drug Administration (FDA).

Actavis hit with lawsuit over generic version of weight-loss drug

Generics/News | Posted 31/07/2015

US-based obesity specialist Orexigen Therapeutics (Orexigen) and its North American partner, Takeda Pharmaceuticals (Takeda), have sued Actavis (Allergan’s US generics business) over its generic version of the weight-loss drug Contrave (naltrexone/bupropion).

Mylan launches generic asthma inhaler in UK

Generics/News | Posted 03/07/2015

US generics manufacturer Mylan announced on 8 June 2015 that it had launched the first bioequivalent alternative to GlaxoSmithKline (GSK)’s asthma inhaler Seretide/Advair (fluticasone/salmeterol) in the UK.

Generics of ADHD drug launched in US

Generics/News | Posted 26/06/2015

Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.

Osteoporosis and ADHD generics launched in USA

Generics/News | Posted 12/06/2015

On 1 and 2 June 2015, Israeli generics giant Teva Pharmaceutical Industries (Teva), launched its latest osteoporosis and ADHD generics, respectively.

FDA receives application for first generic of HIV drug dolutegravir

Generics/News | Posted 05/06/2015

India-based Aurobindo Pharma (Aurobindo) has submitted an abbreviated new drug application (ANDA) for HIV treatment dolutegravir for tentative approval, to the US Food and Drug Administration (FDA).

Generics of high blood pressure medication launched

Generics/News | Posted 22/05/2015

On 31 March 2015, generics majors Mylan, Sandoz and Teva Pharmaceutical Industries (Teva) announced the US launch of their respective generic amlodipine and valsartan combination tablets in four dosages.

TWi and Takeda settle dispute over anti-reflux generic

Generics/News | Posted 15/05/2015

Taiwan-based TWi Pharmaceuticals (TWi) announced on 27 April 2015 that it had entered into a settlement agreement with Takeda Pharmaceutical Company, Takeda Pharmaceuticals USA and Takeda Pharmaceuticals America (Takeda) to settle and dismiss all outstanding patent litigation related to TWi’s generic dexlansoprazole.