Pharma News

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

Glenmark Generics has issued a Class II voluntary recall of 2904 bottles of rantidine Tablets USP, 150 mg, 500-count bottles, prescription only, due to a pharmacist complaint of a "foreign material,"  identified as a metoprolol tartrate...

Mylan Inc. reports that its US-based subsidiary Mylan Pharmaceuticals Inc. has launched Xulane™ (norelgestromin/ethinyl estradiol transdermal system 150/35 mcg per day), the generic version of Janssen Pharmaceuticals Inc.'s Ortho Evra®...

Teva Pharmaceutical Industries Ltd. reports that its subsidiary, Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer related to Teva's generic version of the anti-arthritis drugCelebrex® (celecoxib) 50-, 100-, 200- and...

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...