Glenmark's Baddi semi-solids manufacturing facility gets US FDA nod (PharmaBiz)
Glenmark Pharmaceuticals Ltd has received US FDA approval for its state of the art semi-solids (ointments & creams) manufacturing plant at Baddi, Himachal Pradesh. This is the third Glenmark manufacturing plant to have been approved by the US FDA.

FDA Grants Medtronic Approval To Begin Clinical Trial Of First Pacemaker System Designed For Safe Use In MRI Machines (Medical News Today)
Medtronic, Inc. (NYSE: MDT) announced the start of a United States clinical trial to confirm the safety and efficacy of the Medtronic EnRhythm MRI(TM) SureScan(TM) pacing system, the first-ever pacemaker system to be developed and tested specifically for safe use in Magnetic Resonance Imaging (MRI) machines under specified scanning conditions.

Merck Receives Not Approvable Letter From FDA For OTC MEVACOR (lovastatin) 20 Mg (Medical News Today)
Merck & Co., Inc. received a not approvable letter from the U.S Food and Drug Administration (FDA) to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR (lovastatin) 20 mg. MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews in 2000 and 2005 resulted in not approvable actions.