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FDA adds Boxed Warning to clopidogrel label: drug less effective in poor metabolizers with CYP2C19 gene variant

Sanofi-aventis and Bristol-Myers Squibb announced on 12 March 2010 revisions to the US prescribing information for its anti-blood clotting drug Plavix (clopidogrel bisulfate).

AstraZeneca signs branded-generics deal with Torrent to boost emerging-markets presence

AstraZeneca announced on 11 March 2010 a license and supply agreement with Torrent Pharmaceuticals. Torrent will supply to AstraZeneca a portfolio of generic medicines for which Torrent already has licenses in a range of countries. Working in partnership with Torrent, AstraZeneca intends to brand and market these products in many of its emerging markets, where it already has a strong commercial footprint.

FDA warning letter to Chinese API supplier Xian Libang Pharmaceutical

The FDA has warned Xian Libang Pharmaceutical Co. Ltd, a maker of active pharmaceutical ingredients (APIs); because its quality control unit failed to detect that an employee had manipulated testing data on incoming raw materials. The failure could affect drugmakers that use the company as a supplier. Xian Libang has been asked to provide a list of all lots of APIs shipped to the US that were released based on non-existent, inaccurate or unreliable test data, according to a warning letter of 28 January 2010 recently posted to the FDA’s website.

Daiichi Sankyo unit to sell generic drugs in Japan

Daiichi Sankyo Co. Ltd. said on 26 February 2010 it will set up a new subsidiary in April 2010 to produce and sell generic drugs in Japan, in – according to Mr Kazuhiro Shimamura in the Wall Street Journal Asia – a rare move by a domestic maker of branded prescription drugs to tap the growing market of low-priced pharmaceuticals.

FDA: Counterfeit orlistat has risky sibutramine amount

As reported by Scrip, the US FDA has re-iterated its concerns about a counterfeit version of GlaxoSmithKline's Alli (orlistat), which contains varying degrees of sibutramine rather than the correct active ingredient.

Biovail says Teva’s generic bupropion trial is too small

As reported by Reuters, Biovail, Canada's biggest publicly traded pharmaceutical company said on 22 January 2010 that it believes a proposed clinical trial by Teva of a generic version of Biovail's sustained-release Wellbutrin XL (bupropion) antidepressant drug is too small and brief to be effective.

India urges WHO to ‘clearly promote’ generics

As reported by Scrip on 25 January 2010, India has urged the World Health Organization (WHO) to ‘clearly promote’ generic drugs as a strategy for rational drug use.

Teva’s hedge with generic enoxaparin versus branded glatimir

In the IN VIVO Blog of 14 January 2010, FDC-Windhover’s Biopharma Group Editor-in-Chief Michael McCaughan wrote that – apart from developing a long-term biosimilars strategy (as of 2015) – no one is in quite the same position in complex generics as Teva.

AstraZeneca, Teva settle Nexium, Prilosec patent disputes

AstraZeneca has deferred the threat to its blockbuster drug Nexium (esomeprazole magnesium) in a settlement with Israel's Teva that is likely to delay generic competition for a further four years.

EU regulators request details of drug patent settlements

The European Commission reported on 12 January 2010 that it requested information from several drugmakers in relation to patent settlement agreements made between July 2008 and December 2009.

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