New Drug Approvals Archive for 2007

Olux-E (clobetasol propionate) Foam

Date of Approval: January 12, 2007
Company: Stiefel Laboratories, Inc.
Treatment for: Psoriasis, Eczema

Olux-E (clobetasol propionate) is a topical steroid formulated in VersaFoam emulsion foam drug delivery vehicle indicated for the treatment of psoriasis and eczema in patients 12 years of age or older.

• Olux-E Stiefel Laboratories, Inc. - Treatment for Psoriasis and Eczema
• Olux-E (clobetasol propionate) FDA Approval History

Lialda (mesalamine) Delayed Release Tablets

Date of Approval: January 16, 2007
Company: Shire plc
Treatment for: Ulcerative Colitis

Lialda (mesalamine) is a locally acting 5-aminosalicylic acid (5-ASA) indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

• Lialda Shire plc - Treatment for Ulcerative Colitis
• Lialda (mesalamine) FDA Approval History

Lialda (mesalamine) Delayed Release Tablets

Date of Approval: January 16, 2007
Company: Shire plc
Treatment for: Ulcerative Colitis

Lialda (mesalamine) is a locally acting 5-aminosalicylic acid (5-ASA) indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

• FDA Approves Lialda (mesalamine), the First Oral Once-Daily Mesalamine for Patients With Active, Mild to Moderate Ulcerative Colitis
• Lialda (mesalamine) FDA Approval History

Flector (diclofenac epolamine) Topical Patch

Date of Approval: January 31, 2007
Company: Institut Biochimique SA
Treatment for: Pain

Flector is a transdermal patch formulation of the nonsteroidal anti-inflammatory drug diclofenac, indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

• Flector Approved - Institut Biochimique SA - Treatment for acute pain due to minor strains, sprains, and contusions.
• Flector (diclofenac epolamine) FDA Approval History

Amrix (cyclobenzaprine) Extended-Release Capsules

Date of Approval: February 1, 2007
Company: ECR Pharmaceuticals
Treatment for: Muscle Spasm

Amrix is an extended-release formulation of the skeletal muscle relaxant cyclobenzaprine, indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

• Amrix Approved - ECR Pharmaceuticals - relief of muscle spasm associated with acute, painful musculoskeletal conditions
• Amrix (cyclobenzaprine) FDA Approval History

Alli (orlistat) 60 mg Capsules

Date of Approval: February 7, 2007
Company: GlaxoSmithKline Consumer Healthcare
Treatment for: Weight Loss (Obesity/Overweight)

Alli is an over-the-counter weight-loss product containing orlistat, the same ingredient in prescription strength Xenical. Alli is indicated for weight loss in overweight adults 18 years and older when used along with a reduced-calorie, low-fat diet.

• FDA Approves alli (orlistat 60 mg capsules) Over-The-Counter
• Alli (orlistat) FDA Approval History

Vyvanse (lisdexamfetamine dimesylate) Capsules

Date of Approval: February 23, 2007
Company: Shire plc
Treatment for: ADHD

Vyvanse (lisdexamfetamine dimesylate) is an amphetamine derivative prodrug administered once-daily for the treatment of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder.

• Shire Receives FDA Approval of Vyvanse for ADHD
• Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

Tekturna (aliskiren) Tablets and Oral Pellets - formerly Rasilez

Date of Approval: March 5, 2007
Company: Novartis
Treatment for: High Blood Pressure

Tekturna (aliskiren) is a direct renin inhibitor indicated as a once-daily oral therapy for the treatment of high blood pressure.

• Tekturna - The First New Type of High Blood Pressure Medicine In More Than a Decade - Receives Its First Approval in the US
• Tekturna (aliskiren) FDA Approval History

Tykerb (lapatinib ditosylate) Tablets

Date of Approval: March 13, 2007
Company: GlaxoSmithKline
Treatment for: Breast Cancer

Tykerb (lapatinib) is a kinase inhibitor indicated for the combination treatment of patients with advanced or metastatic breast cancer.

• FDA Approves Tykerb (lapatinib) in Combination With Xeloda(capecitabine) for the Treatment of Advanced or Metastatic BreastCancer in Women Who Have Progressed on Prior Therapy
• Tykerb (lapatinib ditosylate) FDA Approval History

Soliris (eculizumab) Injection

Date of Approval: March 16, 2007
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorder

Soliris (eculizumab) is a complement inhibitor used in the treatment of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, myasthenia gravis, and neuromyelitis optica spectrum disorder.

• FDA Approves Soliris (eculizumab) for Paroxysmal Nocturnal Hemoglobinuria
• Soliris (eculizumab) FDA Approval History

Ceprotin (protein C) Injection

Date of Approval: March 30, 2007
Company: Baxter Healthcare Corporation
Treatment for: Protein C Deficiency

Ceprotin is a plasma-derived Protein C concentrate for use as replacement therapy in patients with life-threatening blood-clotting complications related to severe congenital Protein C deficiency.

• Baxter Announces FDA Approval Of Ceprotin For Severe Congential Protein C Deficiency
• Ceprotin (protein C) FDA Approval History

Janumet (metformin and sitagliptin) Tablets

Date of Approval: March 30, 2007
Company: Merck & Co., Inc.
Treatment for: Type 2 Diabetes

Janumet is a combination of the oral antihyperglycemic drugs sitagliptin and metformin indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus.

• FDA Approves Janumet for Type 2 Diabetes, Offering Powerful GlucoseControl of a DPP-4 Inhibitor and Metformin in a Single Tablet
• Janumet (metformin and sitagliptin) FDA Approval History

Altabax (retapamulin) Ointment

Date of Approval: April 12, 2007
Company: GlaxoSmithKline
Treatment for: Impetigo

Altabax (retapamulin) is a topical antibiotic indicated for the treatment of impetigo in adults and children aged 9 months and older.

• GSK Announces FDA Approval of Altabax (Retapamulin Ointment), 1%
• Altabax (retapamulin) FDA Approval History

Reclast (zoledronic acid) Injection - formerly Aclasta

Date of Approval: April 16, 2007
Company: Novartis
Treatment for: Paget's Disease, Prevention of Osteoporosis, Prevention of Fractures

Reclast (zoledronic acid) is a bisphosphonate indicated for the treatment for Paget's disease, postmenopausal osteoporosis and prevention of fractures.

• Reclast Receives US Approval as a Highly Effective Treatment for Patients with Paget's Disease of the Bone
• Reclast (zoledronic acid) FDA Approval History

Influenza Virus Vaccine, H5N1 () Injection

Date of Approval: April 17, 2007
Treatment for: Prevention of H5N1 Influenza (Avian Influenza)

Influenza Virus Vaccine, H5N1 is a vaccine indicated for the prevention of H5N1 influenza virus, commonly referred to as avian influenza or "bird flu."

• FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1
• Influenza Virus Vaccine, H5N1 FDA Approval History

Veramyst (fluticasone furoate) Nasal Spray

Date of Approval: April 27, 2007
Company: GlaxoSmithKline
Treatment for: Allergic Rhinitis

Marketing Status: Discontinued

Veramyst (fluticasone furoate) is an intranasal corticosteroid administered once-daily for the treatment of seasonal and year- round allergy symptoms in adults and children two years of age and older.

• FDA Approves Once-Daily Veramyst (fluticasone furoate) Nasal Sprayfor Treatment of Seasonal and Year-Round Allergy Symptoms in Adultsand Children as Young as Two Years
• Veramyst (fluticasone furoate) FDA Approval History

AzaSite (azithromycin) Ophthalmic Solution

Date of Approval: April 27, 2007
Company: InSite Vision Incorporated
Treatment for: Conjunctivitis, Bacterial

AzaSite is an ophthalmic formulation of the well-known, broad-spectrum antibiotic azithromycin indicated for the treatment of bacterial conjunctivitis.

• Inspire Announces FDA Approval Of AzaSite
• AzaSite (azithromycin) FDA Approval History

Perlane (dermal filler)

Date of Approval: May 2, 2007
Company: Medicis
Treatment for: Facial Wrinkles

Perlane is a dermal filler for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds.

• Medicis Announces FDA Approval of Perlane
• Perlane (dermal filler) FDA Approval History

Supprelin-LA (histrelin acetate) Subcutaneous Implant

Date of Approval: May 3, 2007
Company: Indevus Pharmaceuticals, Inc.
Treatment for: Precocious Puberty

Supprelin-LA is a once-yearly implant of the gonadotropin releasing hormone (GnRH) analog histrelin, indicated for the treatment of central precocious puberty (CPP), the premature onset of puberty in children.

• Indevus Announces FDA Approval of Supprelin-LA
• Supprelin-LA (histrelin acetate) FDA Approval History

Neupro (rotigotine) Transdermal System

Date of Approval: May 9, 2007
Company: Schwarz Pharma
Treatment for: Parkinson's Disease, Restless Legs Syndrome

Neupro (rotigotine) is a dopamine agonist transdermal system indicated for the treatment of Parkinson’s disease and Restless Legs Syndrome.

• FDA Approves Schwarz Pharma's Neupro (Rotigotine TransdermalSystem) for the Treatment of Early-Stage Parkinson's Disease in USA
• Neupro (rotigotine) FDA Approval History

Perforomist (formoterol fumarate) Inhalation Solution

Date of Approval: May 11, 2007
Company: Dey, L.P.
Treatment for: COPD

Perforomist is an inhalation solution formulation of the long-acting beta(2)-adrenergic agonist formoterol fumarate, indicated for the long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

• FDA Approves Dey, L.P.'s Perforomist (Formoterol Fumarate) Inhalation Solution for Maintenance Treatment of COPD
• Perforomist (formoterol fumarate) FDA Approval History

Seroquel XR (quetiapine) Tablets

Date of Approval: May 17, 2007
Company: AstraZeneca
Treatment for: Schizophrenia, Bipolar Disorder, Depression

Seroquel XR (quetiapine) is an atypical antipsychotic agent indicated for the acute and maintenance treatment of schizophrenia, bipolar disorder and as an adjunctive treatment to antidepressants in adults with Major Depressive Disorder.

• FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-ReleaseTablets for the Treatment of Schizophrenia
• Seroquel XR (quetiapine) FDA Approval History

Lybrel (levonorgestrel and ethinyl estradiol) Tablets

Date of Approval: May 22, 2007
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Birth Control

Marketing Status: Discontinued

Lybrel (levonorgestrel and ethinyl estradiol) is a low-dose combination contraceptive pill taken continuously (without a pill-free interval) and over time may eliminate scheduled menstrual periods. Lybrel is indicated for the prevention of pregnancy.

• FDA Approves Lybrel, First Low Dose Combination Oral ContraceptiveOffering Women the Opportunity to Be Period-Free Over Time
• Lybrel (levonorgestrel and ethinyl estradiol) FDA Approval History

Xyzal (levocetirizine dihydrochloride)

Date of Approval: May 25, 2007
Company: UCB, Inc. and sanofi-aventis
Treatment for: Allergic Rhinitis, Allergic Urticaria

Xyzal (levocetirizine) is an antihistamine for the relief of symptoms associated with allergic rhinitis and urticaria.

• FDA Approves Xyzal (Levocetirizine Dihydrochloride) Tablets for theRelief of Seasonal and Year Round Allergies, and Chronic Hives
• Xyzal (levocetirizine dihydrochloride) FDA Approval History

Torisel (temsirolimus) Injection

Date of Approval: May 30, 2007
Company: Wyeth Pharmaceuticals, Inc.
Treatment for: Renal Cell Carcinoma

Torisel (temsirolimus), an inhibitor of mTOR kinase, is an antineoplastic agent indicated for the treatment of patients with advanced renal cell carcinoma.

• FDA Approves Torisel, a Targeted First-in-Class mTOR Inhibitor forthe Treatment of Advanced Kidney Cancer
• Torisel (temsirolimus) FDA Approval History

Divigel (estradiol) Gel

Date of Approval: June 4, 2007
Treatment for: Postmenopausal Symptoms

Divigel (estradiol) is a low dose topical estrogen gel, which is applied to the skin of the thigh once daily for the treatment of moderate to severe hot flashes associated with menopause.

• FDA Approves Divigel (estradiol gel) 0.1 Percent for Treatment ofModerate to Severe Hot Flashes Associated with Menopause
• Divigel (estradiol) FDA Approval History

Extina (ketoconazole) Foam

Date of Approval: June 12, 2007
Company: Stiefel Laboratories, Inc.
Treatment for: Seborrheic Dermatitis

Extina Foam is a topical formulation of the antifungal ketoconazole in VersaFoam for the treatment of seborrheic dermatitis.

• FDA Approves Extina for the Treatment of Seborrheic Dermatitis
• Extina (ketoconazole) FDA Approval History

Letairis (ambrisentan) Tablets

Date of Approval: June 15, 2007
Company: Gilead Sciences, Inc.
Treatment for: Pulmonary Arterial Hypertension

Letairis (ambrisentan) is an endothelin receptor antagonist (ERA) indicated for the once-daily oral treatment of pulmonary arterial hypertension.

• U.S. Food and Drug Administration Approves Gilead's Letairis (ambrisentan) 5 mg and 10 mg Tablets for the Once-Daily Treatment of Pulmonary Arterial Hypertension (WHO Group 1) in Patients with WHO Functional Class II or III Symptoms
• Letairis (ambrisentan) FDA Approval History

Nuvigil (armodafinil) Tablets

Date of Approval: June 15, 2007
Company: Cephalon, Inc.
Treatment for: Narcolepsy

Nuvigil (armodafinil) is a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD).

• Cephalon Receives FDA Approval of Nuvigil for the Treatment ofExcessive Sleepiness Associated with Three Disorders
• Nuvigil (armodafinil) FDA Approval History

Exforge (amlodipine and valsartan) Tablets

Date of Approval: June 20, 2007
Company: Novartis
Treatment for: High Blood Pressure

Exforge is a single-tablet combination of an angiotensin receptor blocker (valsartan) and a calcium channel blocker (amlodipine) taken once-daily for the treatment of hypertension.

• Exforge Receives Final US Approval as New and Powerful TreatmentOption for Patients With High Blood Pressure
• Exforge (amlodipine and valsartan) FDA Approval History

Endometrin (progesterone) Vaginal Insert

Date of Approval: June 21, 2007
Company: Ferring Pharmaceuticals, Inc.
Treatment for: Female Infertility

Endometrin is a progesterone vaginal insert indicated to support embryo implantation and early pregnancy as part of an Assisted Reproductive Technology (ART) treatment for infertile women.

• FDA Approves Ferring Pharmaceuticals' Endometrin for Luteal Phase Support in Assisted Reproductive Technology Treatment
• Endometrin (progesterone) FDA Approval History

Atralin (tretinoin) Gel

Date of Approval: July 26, 2007
Company: Coria Laboratories, Ltd.
Treatment for: Acne

Atralin (tretinoin) gel is a retinoid indicated for topical treatment of acne vulgaris.

• FDA Approves Atralin Gel for Topical Treatment of Acne Vulgaris
• Atralin (tretinoin) FDA Approval History

Privigen (immune globulin intravenous (human)) Liquid

Date of Approval: July 26, 2007
Company: CSL Behring
Treatment for: Primary Immunodeficiency Syndrome, Immune Thrombocytopenia, Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of primary humoral immunodeficiency (PI), chronic immune thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

• CSL Behring Announces FDA Approval of Privigen-- First Proline-Stabilized 10 Percent Liquid IVIg
• Privigen (immune globulin intravenous (human)) FDA Approval History

CaloMist (cyanocobalamin) Nasal Spray

Date of Approval: July 27, 2007
Company: Fleming & Company, Pharmaceuticals
Treatment for: Vitamin B12 Deficiency

Marketing Status: Discontinued

CaloMist is a nasal spray formulation of cyanocobalamin indicated for the maintenance of vitamin B12 concentrations in patients with vitamin B12 deficiency who have been normalized with intramuscular vitamin B12 therapy.

• FDA Approves CaloMist Nasal Spray for Vitamin B12 Deficiency
• CaloMist (cyanocobalamin) FDA Approval History

EvaMist (estradiol) Transdermal Spray

Date of Approval: July 27, 2007
Company: VIVUS, Inc.
Treatment for: Postmenopausal Symptoms

EvaMist is an estradiol transdermal spray administered once daily for the treatment of vasomotor symptoms (hot flashes) associated with menopause.

• KV Pharmaceutical Announces U.S. Food and Drug Administration Approval of EvaMist
• EvaMist (estradiol) FDA Approval History

Selzentry (maraviroc) Tablets

Date of Approval: August 6, 2007
Company: ViiV Healthcare
Treatment for: HIV Infection

Selzentry (maraviroc) is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older.

• Pfizer's Selzentry (Maraviroc) Tablets, Novel Treatment for HIV, Approved by FDA
• Selzentry (maraviroc) FDA Approval History

Zingo (lidocaine hydrochloride monohydrate) Dermal PowderJect

Date of Approval: August 16, 2007
Company: Anesiva, Inc.
Treatment for: Local Anesthesia

Zingo (lidocaine hydrochloride monohydrate) is a needle-free, local anesthetic intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws.

• Anesiva Receives FDA Approval for Zingo, a New, Innovative Productto Reduce Pain Associated with Needle Insertion Procedures inChildren
• Zingo (lidocaine hydrochloride monohydrate) FDA Approval History

Evithrom (human thrombin)

Date of Approval: August 27, 2007
Company: Omrix Biopharmaceuticals, Ltd,
Treatment for: Bleeding Disorder

Evithrom is a highly purified human thrombin used as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.

• FDA Approves Evithrom (human thrombin) for Topical Use in Surgery
• Evithrom (human thrombin) FDA Approval History

Somatuline Depot (lanreotide acetate) Injection

Date of Approval: August 30, 2007
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome

Somatuline Depot (lanreotide) is a long acting somatostatin analogue indicated for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.

• Ipsen: Somatuline Depot Receives Marketing Approval in the United States for the Treatment of Acromegaly
• Somatuline Depot (lanreotide acetate) FDA Approval History

ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live)

Date of Approval: August 31, 2007
Company: Emergent BioSolutions, Inc.
Treatment for: Smallpox Prophylaxis, Mpox

ACAM2000 [Smallpox and Mpox (Vaccinia) Vaccine, Live] is a live vaccinia virus vaccine indicated for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection.

• FDA Approves ACAM2000 Vaccine for Protection Against Smallpox
• ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) FDA Approval History

Totect (dexrazoxane)

Date of Approval: September 6, 2007
Company: TopoTarget A/S
Treatment for: Anthracycline Extravasation

Totect (dexrazoxane) is a topoisomerase inhibitor used as a detoxifying agent for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

• Totect Approved in the United States
• Totect (dexrazoxane) FDA Approval History

Azor (amlodipine and olmesartan) Tablets - formerly amlodipine and olmesartan

Date of Approval: September 26, 2007
Company: Cosette Pharmaceuticals, Inc.
Treatment for: High Blood Pressure

Azor is a fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Azor is indicated for the treatment of hypertension.

• Azor Receives FDA Approval for Treatment of High Blood Pressure
• Azor (amlodipine and olmesartan) FDA Approval History

Afluria (influenza virus vaccine, inactivated) Injection

Date of Approval: September 28, 2007
Company: Seqirus
Treatment for: Influenza Prophylaxis

Afluria is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in persons 6 months of age and older.

• CSL Biotherapies Announces FDA Marketing Approval of Afluria
• Afluria (influenza virus vaccine, inactivated) FDA Approval History

Isentress (raltegravir) Tablets

Date of Approval: October 12, 2007
Company: Merck & Co., Inc.
Treatment for: HIV Infection

Isentress (raltegravir) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

• FDA Approves of Isentress (raltegravir)
• Isentress (raltegravir) FDA Approval History

Doribax (doripenem) Injection

Date of Approval: October 12, 2007
Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatment for: Intraabdominal Infection, Urinary Tract Infection

Marketing Status: Discontinued

Doribax (doripenem) is a penem antibacterial indicated for the treatment of complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis.

• FDA Approves Doribax for the Treatment of ComplicatedIntra-Abdominal and Complicated Urinary Tract Infections
• Doribax (doripenem) FDA Approval History

Ixempra (ixabepilone) Injection

Date of Approval: October 16, 2007
Company: R-Pharm US
Treatment for: Breast Cancer

Ixempra (ixabepilone) is a semisynthetic analog of epothilone B indicated for the treatment of patients with metastatic or locally advanced breast cancer.

• FDA Approves Ixempra (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
• Ixempra (ixabepilone) FDA Approval History

Voltaren Gel (diclofenac sodium) Topical Gel

Date of Approval: October 17, 2007
Company: GlaxoSmithKline Consumer Healthcare
Treatment for: Osteoarthritis

Voltaren Gel (diclofenac sodium) is a topical non-steroidal anti-inflammatory (NSAID) medication indicated for the temporary relief of joint pain due to osteoarthritis.

• Voltaren Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
• Voltaren Gel (diclofenac sodium) FDA Approval History

Renvela (sevelamer carbonate) Tablets

Date of Approval: October 19, 2007
Company: Genzyme Corporation
Treatment for: Hyperphosphatemia of Renal Failure

Renvela (sevelamer carbonate) is a calcium-free, metal-free, non-absorbed phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

• FDA Approves Genzyme's Renvela for Dialysis Patients
• Renvela (sevelamer carbonate) FDA Approval History

Tasigna (nilotinib) Capsules

Date of Approval: October 29, 2007
Company: Novartis
Treatment for: Chronic Myelogenous Leukemia

Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML).

• Tasigna Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients with Resistance or Intolerance to Existing Therapies
• Tasigna (nilotinib) FDA Approval History

Combigan (brimonidine tartrate and timolol maleate) Ophthalmic Solution

Date of Approval: October 30, 2007
Company: AbbVie Inc.
Treatment for: Intraocular Hypertension, Glaucoma

Combigan (brimonidine tartrate and timolol maleate) is an alpha adrenergic receptor agonist and beta adrenergic receptor inhibitor combination ophthalmic solution for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.

• Allergan, Inc. Receives FDA Approval for Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
• Combigan (brimonidine tartrate and timolol maleate) FDA Approval History

Mircera (epoetin beta-methoxy polyethylene glycol) Injection

Date of Approval: November 14, 2007
Company: Roche
Treatment for: Anemia Due to Chronic Kidney Disease

Mircera (epoetin beta-methoxy polyethylene glycol) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.

• FDA Approves Mircera: First Renal Anemia Treatment in the US withMonthly Maintenance Dosing
• Mircera (epoetin beta-methoxy polyethylene glycol) FDA Approval History

Triesence (triamcinolone acetonide) Injectable Suspension

Date of Approval: November 29, 2007
Company: Alcon, Inc.
Treatment for: Temporal Arteritis, Uveitis

Triesence (triamcinolone acetonide) is a synthetic corticosteroid indicated for visualization during vitrectomy and treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

• Alcon Receives FDA Approval of Triesence Injectable Triamcinolone Suspension for Use in Eye Surgery
• Triesence (triamcinolone acetonide) FDA Approval History

Kuvan (sapropterin dihydrochloride) Tablets

Date of Approval: December 13, 2007
Company: BioMarin Pharmaceutical Inc.
Treatment for: Phenylketonuria

Kuvan (sapropterin dihydrochloride) is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase to metabolize phenylalanine (Phe). Kuvan is indicated for the treatment of phenylketonuria, an inherited metabolic disease caused by a deficiency of the enzyme phenylalanine hydroxylase.

• BioMarin Announces FDA Approval for Kuvan
• Kuvan (sapropterin dihydrochloride) FDA Approval History

Bystolic (nebivolol)

Date of Approval: December 17, 2007
Company: AbbVie Inc.
Treatment for: High Blood Pressure

Bystolic (nebivolol) is a once daily beta blocker approved for the treatment of hypertension.

• Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension
• Bystolic (nebivolol) FDA Approval History