Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

Mylan Inc. has launched eszopiclone tablets 1 mg, 2 mg and 3 mg, the generic version of Sunovion Pharmaceuticals Inc.'s Lunesta®. Mylan received final FDA approval for its abbreviated new drug application (ANDA) for this product, which is...

Mylan Inc. and its partner Famy Care Ltd. have entered into a settlement and license agreement with Warner Chilcott Company, LLC (now part of Actavis), settling the parties' litigation in connection with Mylan's filing of an abbreviated new drug...

Prosonix, a specialty pharmaceutical company developing a portfolio of inhaled respiratory drugs, has entered into a global licensing agreement with Mylan Inc. for the company's inhaled respiratory products, PSX1001 and PSX1050.   PSX1001 and...

Merck & Co. reports that FDA has approved Grastek ® (Timothy grass pollen allergen extract) for sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. Grastek ® is an allergen extract indicated as immunotherapy for the treatment of grass...

GlaxoSmithKline has received FDA approval for Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with Type 2 diabetes. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a...

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. has resubmitted Impax's new drug application (NDA) for Rytaryâ„¢   (IPX066) to FDA. IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa,...

Lupin Pharmaceuticals Inc., Baltimore, has initiated a nationwide voluntary recall of 9,210 bottles of its antibiotic Suprax (cefixime) for oral suspension USP 500 mg/5 ml, 10 mL (when reconstituted), precscription only, The Class III recall was...

Novartis detailed plans for its previously announced plans to close its site in Horsham, UK this year following a global review of research locations and a consultation process with associates. The company made the announcement in February....

Mylan Inc. reports that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug...

Ian C. Read, chairman and CEO of Pfizer, Inc, was elected chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA)  at the trade association's annual meeting, succeeding Robert J. Hugin, chairman and CEO of Celgene...