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New Drug Approvals Archive for 2008

See also: New Indications and Dosage Forms for 2008

Alvesco (ciclesonide) Inhalation Aerosol

Date of Approval: January 10, 2008
Company: Nycomed
Treatment for: Asthma

Alvesco (ciclesonide) is an inhaled corticosteroid indicated for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older.

Flo-Pred (prednisolone acetate) Oral Suspension

Date of Approval: January 17, 2008
Company: Taro Pharmaceutical Industries Ltd.
Treatment for: Asthma, Inflammatory Conditions

Marketing Status: Discontinued

Flo-Pred (prednisolone acetate) is a cherry flavored oral liquid corticosteroid formulation which does not require refrigeration and does not require shaking prior to use. Flo-Pred is an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications.

Recothrom (Thrombin, topical (Recombinant)) - formerly rhThrombin

Date of Approval: January 17, 2008
Company: ZymoGenetics, Inc.
Treatment for: Hemostasis During Surgery

Recothrom is a recombinant form of human thrombin indicated 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. Recothrom may be used in conjunction with an absorbable gelatin sponge, USP.

Intelence (etravirine) Tablets - formerly TMC125

Date of Approval: January 18, 2008
Company: Tibotec Pharmaceuticals Ltd.
Treatment for: HIV Infection

Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets

Date of Approval: January 18, 2008
Company: Novartis Pharmaceuticals Corporation
Treatment for: High Blood Pressure

Tekturna HCT (aliskiren and hydrochlorothiazide) is a single-tablet combination therapy for the treatment of high blood pressure.

Moxatag (amoxicillin) Extended Release Tablets

Date of Approval: January 23, 2008
Company: Pragma
Treatment for: Tonsillitis/Pharyngitis

Marketing Status: Discontinued

Moxatag is a once-daily extended-release formulation of the penicillin antibiotic amoxicillin indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).

Accretropin (somatropin (rDNA origin)) Subcutaneous Injection

Date of Approval: January 23, 2008
Company: Emergent
Treatment for: Pediatric Growth Hormone Deficiency, Turner Syndrome

Marketing Status: Discontinued

Accretropin (somatropin (rDNA origin)) is recombinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

Simcor (niacin ER and simvastatin) Tablets

Date of Approval: February 15, 2008
Company: Abbott
Treatment for: High Cholesterol

Marketing Status: Discontinued

Simcor (niacin extended-release/simvastatin) is a fixed-dose combination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.

Xyntha (antihemophilic factor (recombinant), plasma/albumin free )

Date of Approval: February 21, 2008
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Hemophilia A

Xyntha (Antihemophilic Factor (Recombinant) Plasma/Albumin Free) is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.

Arcalyst (rilonacept) Injection - formerly Interleukin-1 Trap

Date of Approval: February 27, 2008
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Cryopyrin-Associated Periodic Syndromes; Deficiency of Interleukin-1 Receptor Antagonist; Recurrent Pericarditis

Arcalyst (rilonacept) is an interleukin-1 inhibitor indicated for the:

  • treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older
  • maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more
  • treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older.

Pristiq (desvenlafaxine) Extended-Release Tablets

Date of Approval: February 29, 2008
Company: Wyeth Pharmaceuticals
Treatment for: Depression

Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause.

Fusilev (levoleucovorin) for Injection

Date of Approval: March 7, 2008
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Fusilev (levoleucovorin calcium) is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists, and for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

Artiss (fibrin sealant (human)) Topical Solution

Date of Approval: March 19, 2008
Company: Baxter Healthcare Corporation
Treatment for: Burns, External

Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients and for tissue adherence in facial rhytidectomy (face-lift) surgery.

Treanda (bendamustine hydrochloride) Injection

Date of Approval: March 20, 2008
Company: Cephalon, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent non-Hodgkin's lymphoma.

Rotarix (rotavirus vaccine, live attenuated) Oral Suspension

Date of Approval: April 3, 2008
Company: GlaxoSmithKline
Treatment for: Prevention of Rotavirus Gastroenteritis

Rotarix (rotavirus vaccine live) is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.

Lexiscan (regadenoson) Injection

Date of Approval: April 10, 2008
Company: CV Therapeutics, Inc.
Treatment for: Diagnosis and Investigation

Lexiscan (regadenoson) is an A2A adenosine receptor agonist indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress.

Treximet (sumatriptan succinate and naproxen sodium) Tablets - formerly Trexima

Date of Approval: April 15, 2008
Company: Pernix Therapeutics Holdings, Inc.
Treatment for: Migraine

Treximet is a combination of sumatriptan (a migraine-specific triptan) and naproxen (an anti-inflammatory pain reliever) in a single tablet for the acute treatment of migraine.

Patanase (olopatadine hydrochloride) Nasal Spray

Date of Approval: April 15, 2008
Company: Alcon, Inc.
Treatment for: Allergic Rhinitis

Patanase (olopatadine) is an antihistamine nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents twelve years of age and older.

Cimzia (certolizumab pegol) Injection

Date of Approval: April 22, 2008
Company: UCB, Inc.
Treatment for: Crohn's Disease, Acute, Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.

Aplenzin (bupropion hydrobromide) Extended-Release Tablets - formerly BVF-033

Date of Approval: April 23, 2008
Company: Biovail Corporation
Treatment for: Depression

Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.

Relistor (methylnaltrexone bromide) Tablets and Subcutaneous Injection

Date of Approval: April 25, 2008
Company: Salix Pharmaceuticals, Inc.
Treatment for: Constipation

Relistor (methylnaltrexone) is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.

OraVerse (phentolamine mesylate) Injection

Date of Approval: May 9, 2008
Company: Novalar Pharmaceuticals, Inc.
Treatment for: Reversal of Anesthesia

OraVerse is a dental anesthetic reversal agent that accelerates the return to normal sensation and function following dental procedures.

Entereg (alvimopan) Capsules

Date of Approval: May 20, 2008
Company: Adolor Corporation
Treatment for: Postoperative Ileus

Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.

Trivaris (triamcinolone acetonide) Intravitreal Injection

Date of Approval: June 16, 2008
Company: Allergan, Inc.
Treatment for: Ocular Inflammatory Conditions

Marketing Status: Discontinued

Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)

Date of Approval: June 20, 2008
Company: Sanofi pasteur
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Haemophilus influenzae Prophylaxis

Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.

PrandiMet (repaglinide and metformin) Tablets

Date of Approval: June 23, 2008
Company: Sciele Pharma, Inc. and Novo Nordisk Inc.
Treatment for: Diabetes, Type 2

Marketing Status: Discontinued

PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, indicated for the treatment of type 2 diabetes.

Durezol (difluprednate) Ophthalmic Emulsion

Date of Approval: June 23, 2008
Company: Sirion Therapeutics, Inc.
Treatment for: Postoperative Ocular Inflammation

Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.

Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Date of Approval: June 24, 2008
Company: GlaxoSmithKline
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis Prophylaxis, Pertussis Prophylaxis

Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] is a combination vaccine for protection against diphtheria, tetanus, pertussis and polio diseases in children.

Evolence (dermal filler)

Date of Approval: June 27, 2008
Company: OrthoNeutrogena
Treatment for: Facial Wrinkles

Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

Eovist (gadoxetate disodium)

Date of Approval: July 3, 2008
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnosis and Investigation

Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) Intraocular Irrigating Solution

Date of Approval: July 24, 2008
Company: Alcon Laboratories, Inc.
Treatment for: Intraocular Irrigation

Marketing Status: Discontinued

Navstel is a balanced salt ophthalmic solution for use as an intraocular irrigation during surgical procedures involving perfusion of the eye.

Stavzor (valproic acid) Capsules

Date of Approval: July 29, 2008
Company: Noven Pharmaceuticals, Inc.
Treatment for: Bipolar Disorder, Seizures, Epilepsy, Migraine Prevention

Marketing Status: Discontinued

Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.

Cleviprex (clevidipine butyrate) Injectable Emulsion

Date of Approval: August 1, 2008
Company: The Medicines Company
Treatment for: High Blood Pressure

Cleviprex (clevidipine) is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.

Xenazine (tetrabenazine)

Date of Approval: August 15, 2008
Company: Prestwick Pharmaceuticals, Inc.
Treatment for: Huntington’s Chorea

Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.

Nplate (romiplostim)

Date of Approval: August 22, 2008
Company: Amgen Inc.
Treatment for: Idiopathic Thrombocytopenic Purpura

Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Sancuso (granisetron) Transdermal Patch

Date of Approval: September 12, 2008
Company: ProStrakan Group plc
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.

AdreView (iobenguane I 123) Injection

Date of Approval: September 19, 2008
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.

Akten (lidocaine hydrochloride) Ophthalmic Gel

Date of Approval: October 7, 2008
Company: Akorn, Inc.
Treatment for: Ocular Anesthesia

Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

Rapaflo (silodosin) Capsules

Date of Approval: October 8, 2008
Company: Allergan, Inc.
Treatment for: Benign Prostatic Hyperplasia

Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate.

Cinryze (C1 esterase inhibitor (human)) Injection

Date of Approval: October 10, 2008
Company: Shire plc
Treatment for: Hereditary Angioedema

Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE).

Acanya (benzoyl peroxide and clindamycin phosphate) Topical Gel

Date of Approval: October 21, 2008
Company: Dow Pharmaceutical Sciences, Inc.
Treatment for: Acne

Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

LoSeasonique (ethinyl estradiol and levonorgestrel) Extended-Cycle Oral Contraceptive Tablets

Date of Approval: October 24, 2008
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Birth Control

LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

Vimpat (lacosamide) Tablets, Injection, Oral Solution

Date of Approval: October 28, 2008
Company: UCB
Treatment for: Seizures

Vimpat (lacosamide) is an anti-convulsant indicated for the treatment of partial-onset seizures in patients 1 month of age and older, and the adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

Toviaz (fesoterodine fumarate) Extended Release Tablets

Date of Approval: October 31, 2008
Company: Pfizer Inc.
Treatment for: Urinary Frequency

Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Apriso (mesalamine) Extended-Release Capsules

Date of Approval: October 31, 2008
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Ulcerative Colitis

Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

Banzel (rufinamide)

Date of Approval: November 14, 2008
Company: Eisai Medical Research Inc.
Treatment for: Lennox-Gastaut Syndrome

Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Promacta (eltrombopag) Tablets

Date of Approval: November 20, 2008
Company: Novartis Pharmaceuticals Corporation
Treatment for: Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Aplastic Anemia

Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, thrombocytopenia in patients with chronic hepatitis C, and patients with severe aplastic anemia.

Nucynta (tapentadol) Tablets

Date of Approval: November 20, 2008
Company: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Treatment for: Pain

Nucynta (tapentadol) is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.

SCE-A (Synthetic Conjugated Estrogens-A) Vaginal Cream

Date of Approval: November 28, 2008
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Postmenopausal Symptoms

Marketing Status: Discontinued

SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.

Lusedra (fospropofol disodium) Injection

Date of Approval: December 12, 2008
Company: Eisai Corporation of North America
Treatment for: Sedation

Marketing Status: Discontinued

Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

Trilipix (fenofibric acid) Delayed-Release Capsules

Date of Approval: December 15, 2008
Company: Abbott
Treatment for: Hypertriglyceridemia, High Cholesterol

Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARα) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.

Mozobil (plerixafor)

Date of Approval: December 15, 2008
Company: Genzyme Corporation
Treatment for: Bone Marrow Transplantation

Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

Oforta (fludarabine phosphate) Tablets

Date of Approval: December 18, 2008
Company: sanofi-aventis U.S.
Treatment for: Chronic Lymphocytic Leukemia

Marketing Status: Discontinued

Oforta (fludarabine phosphate) is an oral nucleoside analogue approved as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL).

Zolpimist (zolpidem tartrate) Oral Spray

Date of Approval: December 19, 2008
Company: NovaDel Pharma, Inc.
Treatment for: Insomnia

Zolpimist is an oral spray formulation of zolpidem, the drug contained in Ambien. Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Ablavar (gadofosveset trisodium) - formerly Vasovist

Date of Approval: December 22, 2008
Company: EPIX Pharmaceuticals, Inc.
Treatment for: Diagnosis and Investigation

Marketing Status: Discontinued

Ablavar (gadofosveset trisodium) is a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

Firmagon (degarelix) for Injection

Date of Approval: December 24, 2008
Company: Ferring Pharmaceuticals, USA
Treatment for: Prostate Cancer

Firmagon (degarelix) is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer.

Latisse (bimatoprost) Ophthalmic Solution

Date of Approval: December 24, 2008
Company: Allergan, Inc.
Treatment for: Hypotrichosis of Eyelashes

Latisse (bimatoprost ophthalmic) is a prostamide indicated for the treatment of hypotrichosis (or reduced amount of hair) of the eyelashes. Growth of the eyelashes is a well documented side effect of bimatoprost which is currently approved as Lumigan for the treatment of glaucoma.

Ryzolt (tramadol) Extended Release Tablets

Date of Approval: December 30, 2008
Company: Labopharm Inc.
Treatment for: Pain

Marketing Status: Discontinued

Ryzolt (tramadol extended release) is a once-daily analgesic indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Nexterone (amiodarone HCl) Injection

Date of Approval: December 24, 2008
Company: Prism Pharmaceuticals
Treatment for: Ventricular Fibrillation, Ventricular Tachycardia

Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Epiduo (adapalene and benzoyl peroxide) Gel

Date of Approval: December 8, 2008
Company: Galderma Laboratories, L.P.
Treatment for: Acne

Epiduo (adapalene and benzoyl peroxide) Gel is a once-daily, topical retinoid and antimicrobial combination for the treatment of acne.

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