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Generics applications under review by EMA – August 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 hepatitis drug to be made available to 80 countries

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.

Lawyers look at new price hike for old drug

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.

Ranbaxy’s manufacturing woes benefit big pharma

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.

Recalls call into question metoprolol generics

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

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.

European regulators give green light to Ranbaxy plant

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

FDA’s faster approval of generics to benefit Indian drugmakers

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).

Natco tries to block hepatitis C patent in India

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).

Generics applications under review by EMA – April 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].

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