Generics

FDA awards grant to study generic transplant drug tacrolimus

Generics/Research | Posted 22/11/2013

The US Food and Drug Administration (FDA) has awarded a federal grant worth US$2.3 million to researchers at the University of Cincinnati, Ohio, USA, in order to continue studies into tacrolimus, a drug commonly used to stop rejection in transplant patients.

First generic 30 mg Focalin XR capsules approved

Generics/News | Posted 22/11/2013

On 18 November 2013, Mylan Pharmaceuticals announced the launch of generic dexmethylphenidate hydrochloride extended-release (ER) capsules, 30 mg.

Price components of pharmaceutical expenditure

Generics/Research | Posted 15/11/2013

In the second of a series of four articles on pharmaceutical expenditure, Vogler and co-authors take a top down approach to the concept of pharmaceutical expenditure and its use as an indicator in healthcare accounting. Here, they look at the differences in outpatient and inpatient price types [1].

Ranbaxy sues Actavis over generic acne drug

Generics/News | Posted 15/11/2013

Indian generics giant Ranbaxy Laboratories (Ranbaxy) is suing US generic drugmaker Actavis to try to stop the latter marketing a generic version of Ranbaxy’s acne drug Absorica (isotretinoin).

Pharmaceutical expenditure as a health-expenditure indicator

Generics/Research | Posted 08/11/2013

Pharmaceutical expenditure is a major indicator in health-expenditure accounting, and is particularly useful to policymakers and researchers in making regional, country and international comparisons, forecasting, and assessing the effect of pharmaceutical policies [1].

South African HCPs told to ‘get their facts straight’ on generics

Generics/General | Posted 08/11/2013

The South African National Association of Pharmaceutical Manufacturers (NAPM) urged healthcare professionals (HCPs) to ‘get their facts straight’ with respect to generics at a special workshop held at the Johannesburg Country Club on 17 October 2013.

Good news for Ranbaxy plant in US

Generics/News | Posted 08/11/2013

Ranbaxy Laboratory’s (Ranbaxy) US-based plant, Ohm Laboratories (Ohm), has successfully passed an FDA inspection, according to an announcement on the generic drugmaker’s website.

Canada-EU trade deal will extend patents for two years

Generics/General | Posted 31/10/2013

On 18 October 2013, Canada and the European Union (EU) reached agreement on a trade deal, which will free the movement of goods, services, investment and labour between the two regions, but has been criticized by generics makers for delaying access to medicines.

FDA approves generic tobramycin inhalation solution

Generics/News | Posted 31/10/2013

Teva Pharmaceutical Industries (Teva) announced on 14 October 2013 that the US Food and Drug Administration (FDA) had granted approval for its abbreviated new drug application (ANDA) for tobramycin inhalation solution.

Making generics of Advair could be difficult

Generics/News | Posted 25/10/2013

GlaxoSmithKline’s (GSK) fears of generics competition for its chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) may be unfounded according to generics manufacturer Teva Pharmaceutical Industries (Teva).

US court paves way for Nexium competition

Generics/News | Posted 18/10/2013

AstraZeneca announced on 2 October 2013 that the US Court of Appeals for the Federal Circuit had lifted a temporary injunction against the US launch of Hanmi Pharmaceutical’s (Hanmi’s) esomeprazole strontium product.

Forest initiates lawsuits over generic Savella

Generics/News | Posted 18/10/2013

Forest Laboratories and Forest Laboratories Holdings (Forest) announced that Forest and Royalty Pharma Collection Trust (Royalty Pharma) are suing several generics manufacturers regarding generics of Savella (milnacipran).

Australians pay too much for generics

Generics/General | Posted 11/10/2013

According to the Consumers Health Forum of Australia (CHF), a body which represents healthcare consumers, Australians are paying way too much for their generic drugs.

FDA approves generic version of cancer drug

Generics/News | Posted 11/10/2013

FDA announced on 16 September 2013 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Roche’s cancer drug Xeloda (capecitabine).

Transplant coordinators’ perception of generic immunosuppressants

Generics/Research | Posted 04/10/2013

Transplant coordinators associate the availability of multiple generic immunosuppression therapies with increased patient confusion, according to a study by Parker and co-authors [1].

Generics applications under review by EMA – 2013 Q3

Generics/General | Posted 04/10/2013

Last update: 4 October 2013

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 27 EU Member States and in Norway, Iceland and Liechtenstein. 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].

Generics of fish oil cholesterol treatment get go ahead

Generics/News | Posted 04/10/2013

A US appeals court ruled on 12 September 2013 that generics companies can develop their own versions of Lovaza, a fish oil-derived drug used to treat high cholesterol, which is currently marketed in the US by GlaxoSmithKline (GSK).

Australian generics association releases new code of practice

Generics/General | Posted 04/10/2013

Australia’s Generic Medicines Industry Association (GMiA) announced on 26 September 2013 the release of the draft third edition of the GMiA Code of Practice, which incorporates a number of new amendments.