Pharma News

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

The specialty pharmaceutical company Valeant Pharmaceuticals International Inc. has made an approximate $45.7 billion unsolicited bid for specialty pharmaceutical company Allergan, Inc.. Allergan has acknowledged the bid, but says it plans to take...

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...