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FDA rejects pseudoephedrine application due to deficiencies

On 11 March 2011 SCOLR Pharmaceuticals announced it had received a letter from the FDA identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for its generic extended-release pseudoephedrine.

Indian generics companies to strengthen in 2011

Dispute with EU resolved

The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.

New ANDAs and patent challenges for Impax Laboratories

Impax Laboratories is facing a whole barrage of patent litigation following its latest Abbreviated New Drug Application (ANDA) filings and approvals with the FDA.

Germany tightens controls on pharmaceutical prices

The German government is contemplating pharmaceutical price control legislation as it battles soaring drug spending. On the one hand Germany is keen to promote the use of generic drugs and generic medicines have already achieved high penetration—75% by volume in 2009. This highlights opportunities for generic manufacturers in Europe's largest, albeit competitive, drug market.

India under attack

India is coming under attack from Big Pharma from all angles it seems. On the one hand the Indian Government has alleged that multinational companies are campaigning against the country’s domestic pharmaceutical industry due to India’s increasing generic global presence. Then on the other hand Novartis has been asked to end its challenge to Indian patent law, with claims that its action could hinder global access to medicine.

Sun Pharma continues to expand its generics portfolio

Sun Pharma is keeping up the momentum in the generics market with several new generics recently gaining FDA approval and with an extensive pipeline on the way. The latest generics to come out of the company include drugs for the treatment of hypertension, allergic rhinitis and depression.

Strong lobbying by Canadian Generics Association

The President of the Canadian Generic Pharmaceutical Association (CGPA), Mr Jim Keon, has been speaking up on behalf of Canadian generic companies in two recent statements. Canada and the EU are currently in negotiations for a comprehensive economic and trade agreement, which they hope to conclude before the end of 2011.

European Parliament gives go-ahead for EU patent

Despite doubts over the legality of the proposed linguistic regime, the European Parliament gave its green light on 15 February 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation’ to launch a common EU patent system without Italy and Spain on board.

Teva again files citizen petition against generic Copaxone

Teva Pharmaceutical Industries announced on 12 December 2010 that the company had filed another Citizen’s Petition (CP) with the FDA requesting that the agency refuse to approve any abbreviated new drug application (ANDA) for generic versions of Copaxone (glatiramer acetate injection).

Teva setbacks

Teva axes 200 jobs as facility remains closed

After stopping all production at its plant in Irvine, California, USA; in April 2010, Teva announced on 20 January 2011 that all 200 jobs will go.