Generics/News

Zydus Cadila and Sandoz generics approvals in North America

Generics/News | Posted 31/05/2021

In April 2021, Zydus Cadila received final approval from the US Food and Drug Administration to market its ibrutinib and macitentan generics. In addition, in May 2021, Sandoz Canada announced the launch of their pirfenidone, a generic version of F. Hoffmann-La Roche’s Esbriet®.

EMA recommends approval of abiraterone and ioflupane (123I) generics

Generics/News | Posted 07/05/2021

The European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended granting marketing authorizations for two generic medicinal products at its April 2021 meeting.

Tentative US approval for Symbicort generic

Generics/News | Posted 23/04/2021

On 8 March 2021, Viatris Inc and Kindeva Drug Delivery LP announced that the US Food and Drug Administration (FDA) has granted the tentative approval of their generic version of Symbicort® (budesonide/formoterol).

EMA recommends approval of abiraterone and thiotepa generics

Generics/News | Posted 02/04/2021

In January and February 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) held meetings that led to positive opinions towards the recommendation for approval of two generics, Abiraterone Accord (abiraterone) and Thiotepa Riemser (thiotepa).

Teva and Sandoz launch new generics

Generics/News | Posted 26/03/2021

In early 2021, Teva Pharmaceuticals announced the US launch of generic versions of NuvaRing® and AZOPT®. During the same period, Sandoz launched its version of Firazyr.

EMA recommends approval of fourth COVID-19 vaccine

Generics/News | Posted 19/03/2021

11 March 2021 saw the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the fourth COVID-19 vaccine. After a thorough evaluation, EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that data on the Janssen vaccine were robust and met the criteria for efficacy, safety and quality.  

Posaconazole, silodosin and droxidopa generics from Lupin and Sandoz

Generics/News | Posted 12/03/2021

Early 2021 saw the launch of two generic versions of posaconazole in Canada and the US. In Canada, the first generic version of the drug was launched by pharmaceutical manufacturer Sandoz Canada on 26 January 2021, along with a generic version of silodosin. These launches were followed by the launch of Lupin’s generic posaconazole in the US in mid-February 2021. During the same period, Lupin also announced the US approval of its generic droxidopa capsules [3].

Biocon and Lupin launch generic tacrolimus capsules in US

Generics/News | Posted 05/02/2021

India-based generics makers Biocon and Lupin have both launched generic tacrolimus capsules in the US.

Teva launches first Truvada and Atripla generics and two digital inhalers

Generics/News | Posted 20/11/2020

On 2 October 2020, Teva Pharmaceuticals announced the launch of the first US Food and Drug Administration (FDA) approved generic versions of Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets for the treatment of HIV-1.

EMA recommends approval of Lenalidomide Mylan

Generics/News | Posted 13/11/2020

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 October 2020 that it recommends granting marketing authorization for the generic medicine Lenalidomide Mylan (lenalidomide).