مرحبا بمستقبل OAPI اشتجت وايد المعهد والدراسه : هذه مجموعه ادويه جديده خلاص APPROVED BY FDA
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

ROFLUMILSAT
Trade name: Daliresp Dosage forms: Tablets Company: Forest Pharmaceuticals, Inc. Date of Approval: March 1, 2011
Treatment for: Chronic Obstructive Pulmonary Disease (COPD)
Daliresp (roflumilast) is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations


AZILSARTAN MEDOXOMIL
Trade name : Edarbi
Dosage forms: Tablets Company: Takeda Pharmaceutical Company Limited
Date of Approval: February 25, 2011 Treatment for: Hypertension
Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) for the treatment of hypertension.


FACTOR XIII CONCENTRATE HUMAN

Trade name: Corifact Company: CSL Behring LLC Date of Approval: February 17, 2011 Treatment for: Factor XIII Deficiency
Corifact (factor XIII concentrate (human)) is a is a fibrin-stabilizing factor concentrate indicated to prevent bleeding in people with congenital Factor XIII deficiency




HYDROXYPROGESTRONE CAPROATE

Trade name: Makena)
Dosage forms: Injection Company: Hologic, Inc.
Date of Approval: February 3, 2011 Treatment for: Premature Labor
Makena (hydroxyprogesterone caproate) is a long acting form of natural progesterone for the prevention of preterm birth in pregnant women with a history of at least one spontaneous preterm birth

GABAPENTIN
Trade name: Gralise
Dosage forms: Extended Release Tablets - Company: Depomed, Inc.
Date of Approval: January 28, 2011 Treatment for: Postherpetic Neuralgia
Gralise (gabapentin) is an extended release, tablet formulation of the approved antiepileptic agent gabapentin, indicated for the once-daily treatment of post-herpetic neuralgia (PHN).

VILAZODONE

Trade name: Viibryd
Dosage forms: Tablets Company: Trovis Pharmaceuticals LLC
Date of Approval: January 21, 2011 Treatment for: Depression
Viibryd (vilazodone) is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist indicated for the treatment of major depressive disorder (MDD).
SPINOSAD

Trade name: Natroba
Dosage forms: Topical Suspension Company: ParaPRO LLC
Date of Approval: January 18, 2011 Treatment for: Lice
Natroba (spinosad) is a pediculicide indicated for the topical treatment of head lice infestations.




IOFLUPANE I 123


Trade name: DaTscan Dosage forms: Injection Company: GE Healthcare Date of Approval: January 14, 2011 Treatment for: Diagnostic
DaTscan (ioflupane I 123 injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

FENTANYL

Trade name: Abstral Dosage forms: Sublingual Tablets Company: Orexo AB Date of Approval: January 7, 2011 Treatment for: Pain
Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients

TESTOSTERONE

Trade name Fortesta Dosage forms: Gel Company: Endo Pharmaceuticals Date of Approval: December 29, 2010 Treatment for: Hypogonadism -- Male
Fortesta (testosterone) Gel is a topical androgen indicated for replacement therapy in male hypogonadism


ALISKIREN + AMLODIPINE+ HYDROCHLOROTHIAZIDE

Trade name: Amturnide Dosage forms: Tablets Company: Novartis Pharmaceuticals Corporation
Date of Approval: December 21, 2010 Treatment for: Hypertension
Amturnide (aliskiren, amlodipine and hydrochlorothiazide) is a direct renin inhibitor, calcium channel blocker and diuretic combination for the treatment of high blood pressure






DROSPIRENONE+ ETHINYL ESTRADIOL+ LEVOMEFOLATE Ca


Trade name: Safyral Dosage forms: Tablets
Company: Bayer HealthCare Pharmaceuticals, Inc. Date of Approval: December 16, 2010
Treatment for: Contraception
Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) is an estrogen/progestin combined oral contraceptive containing a folate, indicated for use by women to prevent pregnancy, and to raise folate levels in women who choose to use an oral contraceptive for contraception



TESTOSTERONE

Trade name: Axiron
Dosage forms: Topical Solution Company: Eli Lilly and Company
Date of Approval: November 23, 2010 Treatment for: Hypogonadism -- Male
Axiron (testosterone) is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone



BACLOFEN
Trade name: Gablofen
Dosage forms: Injection Company: CNS Therapeutics
Date of Approval: November 19, 2010
Treatment for: Cerebral Spasticity, Chronic Spasticity
Gablofen (baclofen) is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity.









MOXIFLOXACIN

Trade name: Moxeza Dosage forms: Ophthalmic Solution
Company: Alcon, Inc. Date of Approval: November 19, 2010
Treatment for: Bacterial Conjunctivitis
Moxeza (moxifloxacin hydrochloride ophthalmic solution) is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

DENOSUMAB


Trade name: Xgeva Dosage forms: Injection
Company: Amgen Inc. Date of Approval: November 18, 2010
Treatment for: Osteolytic Bone Metastases of Solid Tumors
Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

ERIBULIN MESYLATE

Tade name: Halaven Dosage forms: Injection - formerly E7389
Company: Eisai Co., Ltd. Date of Approval: November 15, 2010
Treatment for: Breast Cancer
Halaven (eribulin mesylate) is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer













TESAMORELIN


Trade name: Egrifta
Dosage forms: Injection Company: Theratechnologies
Date of Approval: November 10, 2010
Treatment for: Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy
Egrifta (tesamorelin) is a synthetic analogue of growth hormone releasing factor (GRF) for the treatment of excess abdominal fat in HIV patients with lipodystrophy


SAXAGLIPTIN + METFORMIN


Trade name: Kombiglyze XR Dosage forms: Extended-Release Tablets
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
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