Regulatory and Drug Approvals News
Regulatory Affairs and Drug Approvals News
Arizona Medtech Company's Technology Breakthrough The First To Achieve FDA Approval For See/Treat Ultrasound
Guided Therapy Systems, LLC (GTS), a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound (ITU).
Genentech And Biogen Idec Receive A Complete Response From The FDA For Rituxan For Chronic Lymphocytic Leukemia
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S.
FDA Advisory Committee Finds Data Support The Safety And Effectiveness Of Prevnar 13™ Vaccine For The Prevention Of Invasive Pneumococcal Diseas
Pfizer Inc (NYSE:PFE) announced today that the U.S.
FDA Announces New Warning On Plavix: Avoid Use With Prilosec/Prilosec OTC
Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. New data suggest that when patients take both Prilosec and Plavix, Plavix's ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.
FDA Takes Action Against Dairy Farm And Owner
On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md.
SafeStitch Medical, Inc. Receives FDA Clearance To Market The AMID StaplerTM For Hernia Repairs
SafeStitch Medical, Inc. (OTCBB:SFES) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its AMID StaplerTM in the U.S. with the intended use in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues, including skin.
Pfizer Submits New Pediatric Data For Lipitor(R) (Atorvastatin) To The European Medicines Agency (EMEA)
Pfizer Inc (NYSE:PFE) announced it has submitted pediatric data for Lipitor® (atorvastatin) to the European Medicines Agency (EMEA). Pfizer has also developed a new chewable form of Lipitor, including a pediatric-appropriate 5 mg dose, which is part of this submission.
Basilea's Toctino(R) Receives Marketing Authorization In Canada
Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada.
NeurogesX To Hold Conference Call To Discuss FDA Approval Of Qutenza(TM) (capsaicin) 8% Patch For Treatment Of Postherpetic Neuralgia (PHN)
NeurogesX, Inc. (Nasdaq: NGSX) announces that it will hold a conference call at 8:30a.m. ET (5:30a.m. PT) to discuss the U.S. Food and Drug Administration (FDA) approval of Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles.
