Menu

Generics/General

Generic V13C05

EU Member States suspend generics approvals due to problems at CRO

Generics/General | Posted 12/12/2014

The European Medicines Agency (EMA) announced on 5 December 2014 that some Member States have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at India-based contract research organization (CRO) GVK Biosciences (GVK Bio) Hyderabad site.

Pay for Delay DrugsMoneyGeneric V13F21

Investigation into huge price increases for generics in the US

Generics/General | Posted 21/11/2014

Two US Congressmen have sent letters to 14 drug manufacturers, including several major Indian firms, requesting information about the escalating prices they have been charging for generics.

58 MD002163

FDA names and shames firms for failing to pay generics fees

Generics/General | Posted 24/10/2014

No less than 28 generics makers are currently on the US Food and Drug Administration’s (FDA) GDUFA (Generic Drug User Fee Amendments) Facility Arrears List for failing to pay generics fees for 2013 and 2014.

30 MD001974

Thirty years of generics in the US

Generics/General | Posted 10/10/2014

On 24 September 2014, the US Food and Drug Administration (FDA) celebrated 30 years of generics in the US.

88 MD002468

Generics taskforce for Australia

Generics/General | Posted 26/09/2014

Australia’s Generic Medicines Industry Association (GMiA), which represents companies that manufacture, supply and export generics, has called on the country’s Minister for Industry to convene a Medicine Manufacturing Taskforce.

EMA logo 2 V13F14

Generics applications under review by EMA – August 2014

Generics/General | Posted 19/09/2014

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].

Generic Brand Name V13C01

Generics game changer for Ireland

Generics/General | Posted 31/01/2014

A new pharmacy in Dublin, Ireland, is offering customers savings of up to 80% on the price of drugs by focussing on generics. The news comes in light of legislation passed by both houses of Ireland’s parliament in May 2013, which encourages wider use of generics and generics substitution [1].

Sovaldi Sofosbuvir hep drug V14I12

Generic hepatitis drug to be made available to 80 countries

Generics/General | Posted 12/09/2014

Originator pharma company Gilead Sciences (Gilead) is reportedly close to reaching a deal with generics makers to bring low cost versions of its hepatitis C drug Sovaldi (sofosbuvir) to about 80 developing countries including India, Indonesia, and Pakistan, as well as Egypt, Mongolia, South Africa, and Vietnam.

Pay for Delay DrugsMoneyGeneric V13F21

Lawyers look at new price hike for old drug

Generics/General | Posted 29/08/2014

Two generic drug companies are being investigated by the Connecticut Attorney General’s office following reports of alarming price hikes for the heart medicine digoxin. Possible price fixing by Impax Laboratories (Impax) and Lannet, which manufacture digoxin, is being investigated.

picture 135

Ranbaxy’s manufacturing woes benefit big pharma

Generics/General | Posted 22/08/2014

Import bans by the US Food and Drug Administration (FDA) on generics from four of Ranbaxy Laboratories’ (Ranbaxy) manufacturing sites have prevented the company from launching new generics, allowing brand-name manufacturers to benefit from their extended monopolies.

88 MD002468

Recalls call into question metoprolol generics

Generics/General | Posted 08/08/2014

Recent recalls have vindicated a cardiologist’s warnings about generic versions of a widely used heart drug, Toprol XL (metoprolol).

India planning to extend pricing control to more drugs

Generics/General | Posted 01/08/2014

India is thought likely to increase the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.

Checklist V14A17

European regulators give green light to Ranbaxy plant

Generics/General | Posted 13/06/2014

In what comes as good news for generics maker Ranbaxy, European Regulators have cleared the company’s Toansa plant.

picture30

FDA’s faster approval of generics to benefit Indian drugmakers

Generics/General | Posted 02/06/2014

Indian generics makers are set to benefit from performance goals set by the US Food and Drug Administration (FDA) as part of the Generic Drug User Fee Amendments of 2012 (GDUFA).

Patent 1 V13E17

Natco tries to block hepatitis C patent in India

Generics/General | Posted 23/05/2014

Indian generics maker Natco Pharma (Natco) has asked the Indian patent office not to issue a patent for US-based Gilead Sciences (Gilead) new hepatitis C drug Sovaldi (sofosbuvir).

EMA logo 2 V13F14

Generics applications under review by EMA – April 2014

Generics/General | Posted 09/05/2014

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].

UK launches generic medicines forum

Generics/General | Posted 02/05/2014

The UK’s drug regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) and the British Generic Manufacturers Association (BGMA) announced on 16 April 2014 the launch of a new forum to promote the manufacturing quality of generics.

Generic Brand Name V13C01

FDA defends generics labelling proposal

Generics/General | Posted 25/04/2014

The US Food and Drug Administration’s (FDA) Director of the Center for Drug Evaluation and Research, Dr Janet Woodcock, testified before the Subcommittee on Health, Committee on Energy and Commerce of the US House of Representatives on 1 April 2014, to discuss FDA’s proposed labelling rule for generics.

Clinical Trials 2 V13K29

Results of clinical trials in Europe to be made publicly available

Generics/General | Posted 18/04/2014

It will soon be the law in Europe for all clinical drug trials to be registered and the results reported on a publicly-accessible database. Members of the European Parliament (MEPs) voted on 2 April 2014 by a huge majority to adopt the Clinical Trials Regulation, 547 in favour, 17 against and 13 abstaining.

picture13

FDA discredits study claiming foreign generics tainted

Generics/General | Posted 11/04/2014

Research suggesting that foreign generics are inferior to US generics has been discredited by the FDA’s Center for Drug Evaluation and Research Director Dr Janet Woodcock.