FDA

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

Merck, known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT. 

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ACIPHEX Sprinkle Delayed-Release Capsules 5mg and 10mg for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.  

X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Silex sacroiliac (SI) joint fusion system.

In February, Dr. Lewis Obi, a board-certified plastic surgeon based in Jacksonville, was notified that the FDA approved the Natrelle 410 “Gummy Bear” breast implants for use in the United States. As a result, Obi has become one of the first plastic surgeons in the U.S. to become certified to use these implants with his patients.

The Food and Drug Administration is warning doctors and patients that a widely used antibiotic from Pfizer can cause rare but deadly heart rhythms in some patients.

The agency is adding new warnings to the label of Zithromax, which is commonly used to treat bronchitis, pneumonia and other infections.

Doctors should consider prescribing other antibiotics to patients at risk of heart problems, including those with irregular heartbeats or low levels of potassium or magnesium in their blood.

AMAG Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration has accepted for review the company’s supplemental new drug application for Feraheme Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to adult patients with IDA who have failed or could not take oral iron treatment.

Antares Pharma, Inc. today announced that the New Drug Application (NDA) for OTREXUP, a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet technology, has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. OTREXUP is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has accepted for review the Company’s New Drug Application resubmission for STEDESA (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy. STEDESA is the proposed trade name for eslicarbazepine acetate.

Pharmacyclics, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the investigational oral agent ibrutinib monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and to ibrutinib monotherapy for the treatment of patients with Waldenstrom’s macroglobulinemia (WM), both of which are B-cell malignancies.