Active Pharmaceutical Ingredient API News and Research

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Forest Laboratories to develop and distribute the novel beta blocker Bystolic (nebivolol)

Mylan Inc. has announced that it and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. have amended their January 2006 agreement to commercialize, develop and distribute the novel beta blocker Bystolic (nebivolol), which is currently approved in the United States for the treatment of hypertension.

28 Feb 2008

Perrigo receives FDA OK for OTC Cetirizine Hydrochloride tablets

Perrigo Company has announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.

2 Jan 2008

Mylan announces FDA approval for Cetirizine Hydrochloride tablets

Mylan Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.

2 Jan 2008

Mylan settles Paroxetine Hydrochloride patent license with GlaxoSmithKline

Mylan Inc. has announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into a patent license and settlement agreement with GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GSK's Paxil CR.

24 Oct 2007

Sanofi-aventis announces settlement of average wholesale price suits with DoJ relating to Anzemet

Sanofi-aventis announced today a civil settlement with the U.S. Department of Justice to resolve "Average Wholesale Price" (AWP) lawsuits under the federal False Claims Act relating to Anzemet(R) involving one of its predecessor companies, Aventis Pharmaceuticals Inc. (API).

11 Sep 2007

FDA warns against use of red yeast rice products promoted as high cholesterol treatment

The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites.

12 Aug 2007

Alpharma moves into China with Tongde Pharmaceutical acquisition

Alpharma Inc. has announced it has acquired the assets of Shenzhou Tongde Pharmaceutical Co. Ltd ("Tongde") in Shenzhou City, China.

20 Apr 2007

Coating characterisation of polymer-coated cardiovascular stents

Coating characterisation of polymer-coated cardiovascular stents has been undertaken utilising ToFSIMS, DSIMS and 3DP.

16 Jan 2007

Halozyme Therapeutics receives FDA clearance for Cumulase

Halozyme Therapeutics has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Cumulase for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States for cumulus removal in the IVF process.

20 Apr 2005

Manufacturers in the European active pharmaceutical ingredients market are struggling to overcome a variety of challenges

Manufacturers in the crowded and highly fragmented European active pharmaceutical ingredients (API) market are struggling to overcome a variety of challenges. One of the most pressing of these is the problem of overcapacity.

29 Nov 2004

Cancer rates falling in the US

The nation's leading cancer organizations report that Americans' risk of getting and dying from cancer continues to decline and survival rates for many cancers continue to improve.

3 Jun 2004