Generics/News

Tentative FDA approval for chemotherapy generic

Generics/News | Posted 13/11/2015

Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015.

Sandoz launches authorized fluvastatin generic in US

Generics/News | Posted 06/11/2015

Sandoz, the generics division of Novartis, announced on 16 October 2015 the launch of an authorized generic version of Lescol (fluvastatin) tablets.

Teva launches enlarged prostate generic in the US

Generics/News | Posted 30/10/2015

Generics giant Teva Pharmaceutical Industries (Teva) announced on 12 October 2015 the exclusive launch of generic dutasteride capsules (0.5 mg) in the US.

ADHD generic receives US FDA approval

Generics/News | Posted 23/10/2015

US generics maker Impax Laboratories (Impax) announced on 21 October 2015 that the company had received approval for its attention deficit hyperactivity disorder (ADHD) guanfacine generic.

Sanofi launches authorized leflunomide generic in US

Generics/News | Posted 16/10/2015

Sanofi US announced on 1 October 2015 that the company’s US generics division, Winthrop, had launched an authorized generic version of Arava (leflunomide) tablets.

Allergan makes deal with Amneal over its Namenda XR generic

Generics/News | Posted 09/10/2015

Allergan has gained some breathing space for the extended-release version of its blockbuster Alzheimer’s disease treatment Namenda XR (memantine XR) after making a deal to delay generics entry for more than four years.

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.