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USP action plan for generics and FDA new innovation office

The US Pharmacopeia (USP) has issued an action plan to promote generics and the US Food and Drug Administration (FDA) has announced the creation of a new office for drug innovation.

Generics applications under review by EMA – January 2019

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].

Non-profit generics maker expects first generics in 2019

Non-profit generics company, Civica Rx announced on 7 January 2019 that it expects to launch its first generics during 2019 and has added 12 new member groups representing 250 hospitals.

Way cleared in US for Suboxone and Zytiga generics

The US Court of Appeals is clearing the way for generics competitors to enter the market. The court has lifted an injunction on Dr Reddy’s Suboxone (buprenorphine/naloxone) generic and upheld a decision to invalidate Johnson & Johnson’s (J&J) patent on its blockbuster prostate cancer drug Zytiga (abiraterone).

FDA approves more generics in 2018 than any other year

The US Food and Drug Administration (FDA) approved 971 generics in 2018, more than in any previous year, according to the Activities Report of the Generic Drug Program (FY 2018).

Brazil to remove backlog for generics

Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) announced on 3 October 2018 that it will eliminate a backlog of new and generic drug applications by January 2019.

Teva sues FDA for changing ‘first applicant’ definition for generics

There is yet another twist in the tale of generics of Allergan’s blockbuster dry eye treatment, Restasis (cyclosporine ophthalmic emulsion). The latest development has Israeli generics giant Teva Pharmaceutical Industries (Teva) suing the US Food and Drug Administration (FDA) for changing its policy on eligibility for 180-day marketing exclusivity for generics.

FDA proposes standardization of generics standards

The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to advance the harmonization of scientific and technical standards for generics.

FDA approves first drug via Competitive Generic Therapy pathway

The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution.

Hospitals launch non-profit generics company

Several major hospital groups announced the official launch of their non-profit generics company, Civica Rx, on 6 September 2018. The company has been created in an effort to combat regular shortages and the increasing prices of drugs.