Generics

FDA approves schizophrenia and anti-allergy drugs

Generics/News | Posted 18/02/2022

The US Food and Drug Administration (FDA) has granted tentative approvals to Zydus Cadila and Morepen Laboratories for treatments for schizophrenia and allergy symptoms, respectively.

Drug shortages hit Japan and Europe

Generics/General | Posted 04/02/2022

Shutdowns of pharmaceutical companies have led to shortages of generic drugs in Japan, while in the EU, existing shortages have been exacerbated by the COVID-19 crisis.

Generics applications under review by EMA – January 2022

Generics/General | Posted 28/01/2022

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Medicines repurposing project launched in Europe

Generics/General | Posted 21/01/2022

In late October 2021, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced the launch of a pilot project to support the repurposing of medicines.

Pfizer to produce generic COVID-19 pill in eight countries of Latin America

Generics/News | Posted 14/01/2022

US-based pharmaceutical company Pfizer announced a licensing agreement to allow other manufacturers to produce generic versions of its COVID-19 pill Paxlovid (PF-07321332*) in order to generate more affordable access to developing countries.

MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments

Generics/General | Posted 10/12/2021

In October and November 2021, Merck and Pfizer signed licensing agreements with the United Nation’s backed Medicines Patent Pool (MPP) to help increase access to their investigational COVID-19 oral antiviral treatment options. Respectively, these are molnupiravir and Paxlovid. Creating these royalty free licences will allow for generic versions of the drugs to be produced and distributed in approximately 100 low- and middle-income countries worldwide.

First eslicarbazepine epilepsy generic to be approved in China

Generics/News | Posted 10/12/2021

In China, the Yangtze River Pharmaceutical Group submitted the first marketing application of a class 3 generic drug, eslicarbazepine acetate, for use to treat patients with epilepsy, on 15 October 2021.

FDA closes Zhejiang Huahai Pharmaceutical warning letter

Generics/General | Posted 19/11/2021

The US Food and Drug Administration (FDA) has stated that it has closed the warning letter issued to Chinese manufacturer Zhejiang Huahai Pharmaceutical in 2018.

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.

FDA reaches 100 generics approvals

Generics/General | Posted 12/11/2021

As of September 2021, the US Food and Drug Administration (FDA) has reached an important milestone of approving more than 100 generic drug applications with a competitive generic therapy (CGT) designation.