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New Drug Approvals Archive for 2007

See also: New Indications and Dosage Forms 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.

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 (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.

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.

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.

Alli (orlistat) 60 mg Capsules

Date of Approval: February 7, 2007
Company: GlaxoSmithKline Consumer Healthcare
Treatment for: Weight Loss

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.

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.

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.

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.

Soliris (eculizumab) Injection

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

Soliris is a complement inhibitor indicated for:

  • the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
  • the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
  • the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
  • the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

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.

Janumet (metformin and sitagliptin) Tablets

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

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.

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.

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.

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."

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

Letairis (ambrisentan) Tablets

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

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

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).

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.

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.

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.

Privigen (immune globulin intravenous (human)) Liquid

Date of Approval: July 26, 2007
Company: CSL Behring
Treatment for: Primary Immunodeficiency Syndrome, Idiopathic Thrombocytopenic Purpura, 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).

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.

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.

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.

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.

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.

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.

ACAM2000 (Smallpox (Vaccinia) Vaccine, Live)

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

ACAM2000 is live vaccinia virus smallpox vaccine intended for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks.

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.

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

Date of Approval: September 26, 2007
Company: Daiichi Sankyo, 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.

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.

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.

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.

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.

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.

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.

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).

Combigan (brimonidine tartrate and timolol maleate) Ophthalmic Solution

Date of Approval: October 30, 2007
Company: Allergan 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.

Mircera (epoetin beta-methoxy polyethylene glycol) Injection

Date of Approval: November 14, 2007
Company: Roche
Treatment for: Anemia Associated with Chronic Renal Failure

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

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.

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.

Bystolic (nebivolol)

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

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

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