Generics/News
FDA approval for generic antibiotic and arrhythmia drugs
Indian generics maker Glenmark Pharmaceuticals (Glenmark) has gained approval for a generic antibiotic, linezolid, and tentative approval for its generic arrhythmia drug dronedarone.
Roche and India's Glenmark reach truce over generic Tarceva
The Swiss pharmaceutical company F. Hoffmann-La-Roche AG (Roche) has reached an out-of-court settlement with Indian generics company Glenmark Pharmaceuticals (Glenmark) over its patent for its lung cancer drug Tarceva (erlotinib hydrochloride).
Cipla, Glenmark, Sun Pharma bidding for Teva–Allergan generics in the US
Indian generics makers Cipla, Glenmark Pharmaceuticals (Glenmark) and Sun Pharmaceutical Industries (Sun Pharma) are reportedly bidding for a portfolio of US generics from Teva Pharmaceutical Industries (Teva).
Dr Reddy’s faces temporary sales ban on generic esomeprazole
A US court has temporarily banned Dr Reddy’s Laboratories from selling its generic version of AstraZeneca’s heartburn drug Nexium (esomeprazole) in the US over allegations of trademark infringement.
Tentative FDA approval for chemotherapy generic
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
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 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
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
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
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.
