Pfizer and Merck COVID-19 antiviral progress

Generics/News | Posted 12/11/2021

Pfizer has announced that its COVID-19 oral antiviral candidate, Paxlovid, can significantly reduce hospitalization and death of COVID patients. At the same time, Merck is under pressure to get its COVID-19 antiviral, molnupiravir, to reach those in developing countries.

Sun Pharma and Dr Reddy’s generics progress in EU and US

Generics/News | Posted 05/11/2021

October 2021 saw the steps forward in the approval of a Sun Pharmaceutical’s sitagliptin fumarate generic in Europe, and Dr Reddy’s lenalidomide generic in the US.

Oncology generics launched by MSN Labs and Natco Pharma

Generics/News | Posted 29/10/2021

In late September 2021, MSN Labs launched Cabolong, a branded generic of Cabozantinib for treatment of renal cell carcinoma in India. This was followed by the early October announcement that in the US, Natco Pharma launched 10 mg strength everolimus tablets, an oncology generic of Novartis’ Afinitor.

Sandoz launches ferumoxytol and pemetrexed generics

Generics/News | Posted 03/09/2021

Sandoz has launched ferumoxytol iron deficiency anaemia (IDA) treatment in the US and pemetrexed oncology treatment in Europe.

US generic approvals for Acrux and Cipla

Generics/News | Posted 16/07/2021

In late June 2021, Australian pharmaceutical company Acrux received United State Food and Drug Administration (FDA) approval to market its generic version of Vallant’s Jubila (efinaconazole). In addition, Indian generics maker Cipla received final FDA approval for a generic version of Sunovion Pharmaceuticals Inc’s Brovana, an arformoterol tartrate inhalation solution.

Natco cancer generic approval and advances for Lannett asthma and diabetes products

Generics/News | Posted 25/06/2021

In early June 2021, US Food and Drug Administration (FDA) approved Natco Pharma’s abbreviated new drug application (ANDA) for carfilzomib vials, a generic version of anticancer drug Kyprolis. It also accepted Lannett’s ANDA for their generic version of asthma treatment Adavir Diskus, fluticasone propionate and salmeterol inhalation powder.

FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin

Generics/News | Posted 21/06/2021

On 27 May 2021, Zydus Cadila received US Food and Drug Administration (FDA) approval to market fluphenazine hydrochloride tablets which is used to treat schizophrenia and other types of mental condition. On 7 June 2021, Lupin Ltd received approval for emtricitabine and tenofovir disoproxil fumarate tablets which are used in combination with other antiretroviral agents for the treatment of HIV. 

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).