Generics/General
Investigation into huge price increases for generics in the US
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.
FDA names and shames firms for failing to pay generics fees
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.
Thirty years of generics in the US
On 24 September 2014, the US Food and Drug Administration (FDA) celebrated 30 years of generics in the US.
Generics taskforce for Australia
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.
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].
Generics game changer for Ireland
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].
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).
