Kombiglyze (saxagliptin; metformin)
Company: Bristol Myers Squibb and AstraZeneca
Date of Approval: November 5, 2010
Indication: Diabetes Mellitus Type 2
The FDA approved Kombiglyze™ XR for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG).
Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.Ofirmev (acetaminophen)
Company: Cadence Pharmaceuticals
Date of Approval: November 2, 2010
Indication: Fever, Pain
The FDA has granted marketing approval for Ofirmev injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. Ofirmev is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.Teflaro (ceftaroline fosamil)
Company: Cerexa Inc.
Date of Approval: October 29, 2010
Indication: Pneumonia, Skin and Structure Infection
The FDA approved Teflaro, an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).
Latuda (lurasidone hydrochloride)
Company: Sunovian Pharma Inc.
Date of Approval: October 28, 2010
The FDA approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia. Schizophrenia affects about 1 percent of the U.S. population, ages 18 years and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and suspiciousness.
Pradaxa (dabigatran etexilate mesylate)
Company: Boehringer Ingelheim
Date of Approval: October 19, 2010
Indication: Prevention of Thromboembolism in Atrial Fibrillation
The FDA approved Pradaxa capsules for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). Atrial fibrillation, which affects more than 2 million Americans, involves very fast and uncoordinated contractions of the heart’s two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.Further drug information, including safety information, warnings, contraindications and other facts about general use, is available online at www.fda.gov/drugs.