Generics/News
FDA approval for guaifenesin generics
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
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 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
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
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
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
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
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
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
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).
