Kombiglyze XR (saxagliptin and metformin)
Company: Bristol-Myers Squibb Company and AstraZeneca
Date of Approval: November 5, 2010
Treatment for: Diabetes Mellitus Type II
Kombiglyze XR (saxagliptin and metformin) is a once-daily fixed dose combination of the dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza (saxagliptin) and extended release metformin for the treatment of type 2 diabetes.
Ofirmev (acetaminophen) Intravenous Injection - formerly Acetavance
Company: Cadence Pharmaceuticals, Inc.
Date of Approval: November 2, 2010
Treatment for: Fever, Pain
Ofirmev (acetaminophen) is an intravenous analgesic product for the treatment of acute pain and fever in adults and children.
Nuedexta (dextromethorphan and quinidine) - formerly Zenvia
Company: Avanir Pharmaceuticals
Date of Approval: October 29, 2010
Treatment for: Pseudobulbar Affect
Nuedexta (dextromethorphan and quinidine) is a first-in-class dual action glutamate inhibitor indicated for the treatment of pseudobulbar affect.
Teflaro (ceftaroline fosamil) Injection
Company: Forest Laboratories, Inc.
Date of Approval: October 29, 2010
Treatment for: Pneumonia, Skin and Structure Infection
Teflaro (ceftaroline fosamil) is a cephalosporin antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Latuda (lurasidone) Tablets
Company: Dainippon Sumitomo Pharma America, Inc.
Date of Approval: October 28, 2010
Treatment for: Schizophrenia
Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia.
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) Tablets
Company: Warner Chilcott plc
Date of Approval: October 21, 2010
Treatment for: Contraception
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) is an estrogen/progestin COC indicated for use by women to prevent pregnancy
Pradaxa (dabigatran etexilate) Capsules
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: October 19, 2010
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
Pradaxa (dabigatran etexilate) is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Bromday (bromfenac) Ophthalmic Solution - formerly XiDay
Company: ISTA Pharmaceuticals, Inc.
Date of Approval: October 16, 2010
Treatment for: Postoperative Ocular Inflammation
Bromday (bromfenac ophthalmic solution) is a once-daily ocular nonsteroidal anti-inflammatory agent for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Gamunex-C (immune globulin subcutaneous (human)) Injection
Company: Talecris Biotherapeutics, Inc.
Date of Approval: October 13, 2010
Treatment for: Primary Immunodeficiency Syndrome
Gamunex-C (immune globulin subcutaneous (human)) is indicated for the treatment of primary immunodeficiency (PI).
Atelvia (risedronate sodium) Delayed-Release Tablets
Company: Warner Chilcott plc
Date of Approval: October 8, 2010
Treatment for: Osteoporosis
Atelvia (risedronate sodium) is a bisphosphonate in a delayed-release formulation for treatment of postmenopausal osteoporosis.
Sorilux (calcipotriene) Foam
Company: Stiefel Laboratories, Inc.
Date of Approval: October 7, 2010
Treatment for: Psoriasis
Sorilux (calcipotriene) Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis in patients aged 18 years and older.
Aridol (mannitol) Inhalation Powder
Company: Pharmaxis Ltd.
Date of Approval: October 5, 2010
Treatment for: Bronchial Challenge Test
Aridol (mannitol inhalation powder) is a bronchial challenge test designed to help in the correct diagnosis and assessment of asthma.
Kapvay (clonidine hydrochloride) Extended-Release Tablets
Company: Shionogi Inc.
Date of Approval: September 28, 2010
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)
Kapvay (clonidine hydrochloride) is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications
Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: September 24, 2010
Treatment for: Contraception, Premenstrual Dysphoric Disorder, Acne
Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) is an estrogen/progestin combined oral contraceptive containing a folate, indicated for use by women to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder, treat moderate acne and to raise folate levels in women who choose to use an oral contraceptive for contraception.
Gilenya (fingolimod) Capsules - formerly FTY720
Company: Novartis
Date of Approval: September 21, 2010
Treatment for: Multiple Sclerosis
Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Krystexxa (pegloticase) Injection - formerly Puricase
Company: Savient Pharmaceuticals, Inc.
Date of Approval: September 14, 2010
Treatment for: Gout
Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
ekamlo (aliskiren and amlodipine) Tablets
Company: Novartis Pharmaceuticals Corporation
Date of Approval: August 26, 2010
Treatment for: Hypertension
Tekamlo (aliskiren and amlodipine) is a direct renin inhibitor and calcium channel blocker combination indicated for the treatment of high blood pressure
ella (ulipristal acetate)
Company: HRA Pharma
Date of Approval: August 13, 2010
Treatment for: Postcoital Contraception
ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) Oral Solution
Company: Braintree Laboratories, Inc.
Date of Approval: August 5, 2010
Treatment for: Bowel Preparation
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
Xeomin (incobotulinumtoxinA)
Company: Merz Pharmaceuticals, LLC
Date of Approval: July 30, 2010
Treatment for: Cervical Dystonia, Blepharospasm
Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of adults with cervical dystonia and blepharospasm.
