New Drug Approvals Archive for 2006

Vivaglobin (immune globulin subcutaneous (human))

Date of Approval: January 9, 2006
Company: ZLB Behring
Treatment for: Primary Immunodeficiency Syndrome

Vivaglobin is a pasteurized, polyvalent human normal immunoglobulin for subcutaneous infusion indicated for the treatment of patients with primary immune deficiency (PID).

• Vivaglobin Approved - ZLB Behring - Treatment for Primary Immunodeficiencies
• Vivaglobin (immune globulin subcutaneous (human)) FDA Approval History

Taclonex (calcipotriene and betamethasone dipropionate) Ointment

Date of Approval: January 9, 2006
Company: LEO Pharma
Treatment for: Psoriasis

Taclonex is a topical ointment containing a combination of calcipotriene and betamethasone for the treatment of psoriasis vulgaris in adults.

• FDA Approves Taclonex - Once Daily Therapy for Treatment of Psoriasis
• Taclonex (calcipotriene and betamethasone dipropionate) FDA Approval History

Sutent (sunitinib malate) Capsules

Date of Approval: January 26, 2006
Company: Pfizer Inc.
Treatment for: Gastrointestinal Stromal Tumor, Renal Cell Carcinoma, Pancreatic Cancer

Sutent (sunitinib malate) is an oral multi-kinase inhibitor indicated for the treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC), adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy, and the treatment of pancreatic neuroendocrine tumors.

• FDA Approves Sutent for Gastrointestinal Stromal Tumors and Advanced Renal Cell Carcinoma
• Sutent (sunitinib malate) FDA Approval History

Ranexa (ranolazine) Extended-Release Tablets

Date of Approval: January 27, 2006
Company: CV Therapeutics, Inc.
Treatment for: Angina

Ranexa (ranolazine) is an antianginal and anti-ischemic agent indicated for the treatment of chronic angina.

• Ranexa Approved - CV Therapeutics, Inc. - Treatment for Chronic Angina
• Ranexa (ranolazine) FDA Approval History

Exubera (insulin inhalation) Powder

Date of Approval: January 27, 2006
Company: Pfizer Inc.
Treatment for: Diabetes, Type 1, Type 2 Diabetes

Marketing Status: Discontinued

Exubera is a rapid-acting, dry powder human insulin inhalation indicated for the treatment of adult patients with diabetes mellitus, either as monotherapy, or in combination with oral agents or longer-acting insulins.

• Exubera Approved - Pfizer Inc - Treatment for Type 1 and Type 2 Diabetes in Adults
• Exubera (insulin inhalation) FDA Approval History

HepaGam B (hepatitis B immune globulin)

Date of Approval: January 30, 2006
Company: Cangene
Treatment for: Exposure to Hepatitis B Virus

HepaGam B is hepatitis B immune globulin (human), a purified antibody or hyperimmune that is specific for the hepatitis B virus. HepaGam B is indicated for treatment following acute exposure to hepatitis B virus.

• HepaGam B - Cangene - Treatment for Exposure to Hepatitis B
• HepaGam B (hepatitis B immune globulin) FDA Approval History

Amitiza (lubiprostone) Capsules

Date of Approval: January 31, 2006
Company: Sucampo Pharmaceuticals, Inc.
Treatment for: Chronic Idiopathic Constipation, Opioid-Induced Constipation, Irritable Bowel Syndrome with Constipation

Amitiza (lubiprostone) is a selective chloride channel activator for the treatment of chronic idiopathic constipation and opioid-induced constipation in adults, and irritable bowel syndrome with constipation in adult women.

• Amitiza - Sucampo Pharmaceuticals, Inc. - Treatment for Constipation
• Amitiza (lubiprostone) FDA Approval History

RotaTeq (rotavirus vaccine, live, oral, pentavalent)

Date of Approval: February 3, 2006
Company: Merck & Co., Inc.
Treatment for: Rotavirus Gastroenteritis

RotaTeq (rotavirus vaccine, live, oral, pentavalent) is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks for the prevention of rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children.

• RotaTeq Approved - Merck & Co., Inc. - Treatment for Prevention of Rotavirus Gastroenteritis
• RotaTeq (rotavirus vaccine, live, oral, pentavalent) FDA Approval History

Vusion (miconazole nitrate, zinc oxide and white petrolatum) Ointment - formerly Zimycan

Date of Approval: February 16, 2006
Company: Barrier Therapeutics, Inc.
Treatment for: Cutaneous Candidiasis

Vusion (miconazole nitrate, zinc oxide and white petrolatum) is a steroid-free ointment for the treatment of diaper dermatitis.

• Vusion Approved - Barrier Therapeutics, Inc. - Treatment for Diaper Dermatitis Complicated by Candidiasis
• Vusion (miconazole nitrate, zinc oxide and white petrolatum) FDA Approval History

Eraxis (anidulafungin) Injection

Date of Approval: February 17, 2006
Company: Pfizer Inc.
Treatment for: Candidemia

Eraxis (anidulafungin) is an antifungal medicine of the echinocandin class, indicated for the treatment of candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) and esophageal candidiasis.

• Eraxis - Pfizer Inc - Treatment for Candidemia
• Eraxis (anidulafungin) FDA Approval History

Loestrin 24 Fe (norethindrone acetate/ethinyl estradiol and ferrous fumarate) Tablets

Date of Approval: February 17, 2006
Company: Warner Chilcott
Treatment for: Birth Control

Loestrin 24 Fe (norethindrone acetate/ethinyl estradiol and ferrous fumarate) is an oral contraceptive providing 24 days of active hormonal therapy with four days of iron containing placebo pills. Loestrin 24 Fe is indicated for the prevention of pregnancy.

• Loestrin 24 Fe Approved - Warner Chilcott - Treatment for Prevention of Pregnancy
• Loestrin 24 Fe (norethindrone acetate/ethinyl estradiol and ferrous fumarate) FDA Approval History

Emsam (selegiline) Transdermal System

Date of Approval: February 27, 2006
Company: Somerset Pharmaceuticals, Inc.
Treatment for: Depression

Emsam is a transdermal patch containing the monoamine oxidase inhibitor selegiline. Emsam is indicated for the treatment of major depressive disorder (MDD) in adults.

• Emsam Approved - Bristol-Myers Squibb Company/Somerset Pharmaceuticals, Inc. - Treatment for Major Depressive Disorder
• Emsam (selegiline) FDA Approval History

Yaz (drospirenone and ethinyl estradiol) Tablets

Date of Approval: March 16, 2006
Company: Berlex, Inc.
Treatment for: Acne, Birth Control, Premenstrual Dysphoric Disorder

Yaz (drospirenone and ethinyl estradiol) is a combination oral contraceptive indicated for prevention of pregnancy in women who elect to use an oral contraceptive, treatment of symptoms of premenstrual dysphoric disorder and for the treatment of moderate acne vulgaris.

• Yaz Berlex, Inc. - Treatment for Prevention of Pregnancy
• Yaz (drospirenone and ethinyl estradiol) FDA Approval History

Daytrana (methylphenidate) Transdermal System - formerly MTS

Date of Approval: April 6, 2006
Company: Shire Pharmaceuticals Group plc / Noven Pharmaceuticals, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Daytrana is a once daily transdermal patch formulation of methylphenidate indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

• Daytrana Approved - Shire plc - Treatment for Attention Deficit Hyperactivity Disorder
• Daytrana (methylphenidate) FDA Approval History

NeoProfen (ibuprofen lysine) Injection

Date of Approval: April 13, 2006
Company: Farmacon-IL, LLC
Treatment for: Patent Ductus Arteriosus

NeoProfen is an intravenous formulation of ibuprofen lysine indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants, who are no more than 32 weeks gestational age when usual medical management is ineffective.

• NeoProfen Approved - Farmacon-IL, LLC - Treatment for Patent Ductus Arteriosus
• NeoProfen (ibuprofen lysine) FDA Approval History

Vivitrol (naltrexone) for Extended-Release Injectable Suspension - formerly Vivitrex

Date of Approval: April 13, 2006
Company: Alkermes, Inc.
Treatment for: Alcohol Use Disorder, Opioid Use Disorder

Vivitrol (naltrexone) is is an opioid antagonist indicated for the treatment of alcohol dependence and opioid dependence.

• FDA Approves Vivitrol (naltrexone) for the Treatment for Alcohol Dependence
• Vivitrol (naltrexone) FDA Approval History

Myozyme (alglucosidase alfa)

Date of Approval: April 28, 2006
Company: Genzyme Corp.
Treatment for: Pompe Disease

Myozyme is a recombinant formulation of the human enzyme acid alpha-glucosidase (GAA) indicated for use in patients with Pompe disease (GAA deficiency), a debilitating and often fatal muscle disorder.

• Myozyme Approved - Genzyme Corp. - Treatment for Pompe Disease
• Myozyme (alglucosidase alfa) FDA Approval History

Oracea (doxycycline) Capsules

Date of Approval: May 26, 2006
Company: CollaGenex Pharmaceuticals, Inc.
Treatment for: Rosacea

Oracea is a once-a-day capsule formulation of doxycycline, consisting a combination of immediate and delayed release beads. Oracea is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients.

• Oracea CollaGenex Pharmaceuticals, Inc. - Treatment for Rosacea
• Oracea (doxycycline) FDA Approval History

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

Date of Approval: May 25, 2006
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Birth Control

Seasonique (levonorgestrel/ethinyl estradiol) is an extended-cycle oral contraceptive regimen designed to reduce the number of withdrawal bleeding periods from monthly to four per year. Seasonique is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of birth control.

• FDA Approves Duramed's Seasonique Extended-Cycle Oral Contraceptive
• Seasonique (levonorgestrel and ethinyl estradiol) FDA Approval History

Orapred ODT (prednisolone sodium phosphate) Orally Disintegrating Tablets

Date of Approval: June 1, 2006
Company: BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc.
Treatment for: Asthma, acute

Orapred ODT is an orally disintegrating tablet formulation of prednisolone, used to treat exacerbations of asthma and other inflammatory diseases and conditions in children. Orapred ODT tablets are grape flavored and can be swallowed whole or allowed to dissolve in the mouth, with or without the assistance of water.

• Orapred ODT BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc. - Treatment for Asthma and other Inflammatory Conditions in Children
• Orapred ODT (prednisolone sodium phosphate) FDA Approval History

Juvederm (dermal filler) Injectable Gel

Date of Approval: June 2, 2006
Company: AbbVie Inc.
Treatment for: Facial Rejuvenation

Juvéderm hyaluronic acid dermal filler products are used for facial rejuvenation.

• Juvederm Allergan, Inc. - Treatment for Facial Wrinkles and Folds
• Juvederm (dermal filler) FDA Approval History

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) Injection

Date of Approval: June 8, 2006
Company: Merck & Co., Inc.
Treatment for: Human Papillomavirus Prophylaxis

Marketing Status: Discontinued

Gardasil (human papillomavirus vaccine) is a recombinant vaccine indicated in girls and women 9 through 26 years of age for the prevention of:

• cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) types 16 and 18
• genital warts (condyloma acuminata) caused by HPV types 6 and 11
• precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18

Gardasil is indicated in boys and men 9 through 26 years of age for the prevention of:

• anal cancer caused by HPV types 16 and 18
• genital warts (condyloma acuminata) caused by HPV types 6 and 11
• precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18

In December 2014, the FDA announced the approval of Gardasil 9 for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. Gardasil 9 adds protection against five additional HPV types - 31, 33, 45, 52 and 58 - which cause approximately 20 percent of cervical cancers.

• FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases
• Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets

Date of Approval: June 14, 2006
Company: Valeant Pharmaceuticals International
Treatment for: Parkinson's Disease

Zelapar (selegiline) is an an irreversible inhibitor of monoamine oxidase (MAO) indicated as an adjunct in the management of patients with Parkinson’s disease.

• Zelapar Valeant Pharmaceuticals International - Treatment for Parkinson’s Disease
• Zelapar (selegiline hydrochloride) FDA Approval History

Opana (oxymorphone) Tablets and ER Tablets

Date of Approval: June 22, 2006
Company: Endo Pharmaceuticals Inc.
Treatment for: Pain

Marketing Status: Discontinued

Opana (immediate-release) and Opana ER (extended-release) are oral formulations of the opioid analgesic oxymorphone, used for the relief of moderate-to-severe pain. Opana is indicated for the relief of acute pain where the use of an opioid is appropriate, and Opana ER is indicated for patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

• Opana ER Endo Pharmaceuticals Inc. - Treatment for Moderate-to-Severe Pain
• Opana (oxymorphone) FDA Approval History

Prezista (darunavir) Tablets - formerly TMC114

Date of Approval: June 23, 2006
Company: Janssen Therapeutics
Treatment for: HIV Infection

Prezista (darunavir) is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.

• Prezista Tibotec Pharmaceuticals Ltd. - Treatment for Human Immunodeficiency Virus (HIV)
• Prezista (darunavir) FDA Approval History

Sprycel (dasatinib) Tablets

Date of Approval: June 28, 2006
Company: Bristol-Myers Squibb Company
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

• Sprycel Bristol-Myers Squibb Company - Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)
• Sprycel (dasatinib) FDA Approval History

Lucentis (ranibizumab) Injection

Date of Approval: June 30, 2006
Company: Genentech, Inc.
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

• FDA Approves Lucentis (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration
• Lucentis (ranibizumab) FDA Approval History

Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets

Date of Approval: July 12, 2006
Company: Bristol-Myers Squibb Company / Gilead Sciences, Inc.
Treatment for: HIV Infection

Atripla is a once-daily single tablet regimen combining the non-nucleoside reverse transcriptase inhibitor Sustiva (efavirenz), and the nucleoside reverse transcriptase inhibitors Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). Atripla is indicated as a stand-alone therapy or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults.

• Atripla Bristol-Myers Squibb Company / Gilead Sciences, Inc. - Treatment for HIV-1 Infection
• Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) FDA Approval History

Implanon (etonogestrel) Implant

Date of Approval: July 18, 2006
Company: Organon
Treatment for: Birth Control

Implanon (etonogestrel) is a single-rod subdermal implant that continually releases a low, steady dose of progestin providing contraceptive effectiveness for a period of up to three years.

• FDA Approves Implanon (etonogestrel implant) for Contraception
• Implanon (etonogestrel) FDA Approval History

Symbicort (budesonide and formoterol) Inhaler

Date of Approval: July 21, 2006
Company: AstraZeneca
Treatment for: Asthma, Maintenance, COPD, Maintenance

Symbicort (budesonide and formoterol) is a combination of a corticosteroid and a long-acting bronchodilator indicated for the long-term maintenance treatment of asthma and the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

• AstraZeneca’s Symbicort (budesonide/formoterol) Treatment For Asthma Approved By The FDA
• Symbicort (budesonide and formoterol) FDA Approval History

Elaprase (idursulfase) Injection

Date of Approval: July 24, 2006
Company: Shire plc
Treatment for: Mucopolysaccharidosis Type II

Elaprase (idursulfase) is a purified form of the human lysosomal enzyme iduronate-2-sulfatase produced by recombinant DNA technology. Elaprase is indicated for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II).

• Elaprase Shire plc - Treatment for Hunter Syndrome
• Elaprase (idursulfase) FDA Approval History

Xolegel (ketoconazole) Gel - formerly Sebazole

Date of Approval: July 28, 2006
Company: Barrier Therapeutics, Inc.
Treatment for: Seborrheic Dermatitis

Xolegel is a topical waterless gel formulation of the antifungal agent ketoconazole, applied once-daily for the treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older.

• Xolegel Gel Barrier Therapeutics, Inc. - Treatment for Seborrheic Dermatitis
• Xolegel (ketoconazole) FDA Approval History

Duetact (pioglitazone HCl and glimepiride) Tablets

Date of Approval: July 31, 2006
Company: Takeda Pharmaceuticals North America, Inc.
Treatment for: Type 2 Diabetes

Duetact is a combination of pioglitazone, which directly targets insulin resistance, and glimepiride, a sulfonylurea that acts primarily by increasing the amount of insulin produced by the pancreas. Duetact is indicated for the treatment of type 2 diabetes.

• Duetact Takeda Pharmaceuticals North America, Inc. - Treatment for Type 2 Diabetes
• Duetact (pioglitazone HCl and glimepiride) FDA Approval History

MoviPrep (polyethylene glycol 3350 with electrolytes) for Oral Solution

Date of Approval: August 2, 2006
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Bowel Preparation

MoviPrep is a two-liter liquid PEG bowel cleansing agent indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

• MoviPrep Salix Pharmaceuticals, Ltd. - Treatment for Bowel Cleansing prior to Colonoscopy
• MoviPrep (polyethylene glycol 3350 with electrolytes) FDA Approval History

Noxafil (posaconazole)

Date of Approval: September 15, 2006
Company: Merck
Treatment for: Fungal Infection Prophylaxis

• Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows:
  • Noxafil injection: adults and pediatric patients 2 years of age and older
  • Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg
  • Noxafil oral suspension: adults and pediatric patients 13 years of age and older
  • Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older (who weigh 40 kg or less)
• Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adult and pediatric patients aged 13 years and older.

• Schering-Plough Announces FDA Approval of Noxafil (posaconazole) for Prevention of Invasive Fungal Infections
• Noxafil (posaconazole) FDA Approval History

Verdeso (desonide) Foam

Date of Approval: September 19, 2006
Company: Connetics Corporation
Treatment for: Dermatitis

Verdeso (desonide) Foam is a low-potency topical steroid formulated in VersaFoam emulsion foam drug delivery vehicle for the treatment of mild-to-moderate atopic dermatitis.

• Verdeso Connetics Corporation - Treatment for Mild-to-Moderate Atopic Dermatitis
• Verdeso (desonide) FDA Approval History

Travatan Z (travoprost) Ophthalmic Solution

Date of Approval: September 21, 2006
Company: Alcon, Inc.
Treatment for: Glaucoma

Travatan Z (travoprost) is a new formulation of Travatan solution in which benzalkonium chloride is replaced with Sofzia, a robust ionic buffered preservative system that is gentle to the ocular surface. Travatan Z is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications.

• Travatan Z Alcon, Inc. - Treatment for Glaucoma and Ocular Hypertension
• Travatan Z (travoprost) FDA Approval History

Fentora (fentanyl) Buccal Tablets - formerly OraVescent Fentanyl

Date of Approval: September 25, 2006
Company: Cephalon, Inc.
Treatment for: Pain

Fentora is an effervescent buccal formulation of the potent opioid analgesic fentanyl, indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

• Fentora Cephalon, Inc. - Treatment for Breakthrough Pain in Patients with Cancer
• Fentora (fentanyl) FDA Approval History

Vectibix (panitumumab) Injection

Date of Approval: September 27, 2006
Company: Amgen Inc.
Treatment for: Colorectal Cancer

Vectibix (panitumumab) is an epidermal growth factor receptor (EGFR) antagonist for use in the treatment of wild-type RAS metastatic colorectal cancer and KRAS G12C-mutated metastatic colorectal cancer.

• FDA Approves Vectibix (panitumumab) to Treat Patients with Metastatic Colorectal Cancer
• Vectibix (panitumumab) FDA Approval History

Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) Capsules - formerly Helizide

Date of Approval: September 28, 2006
Company: Allergan, Inc.
Treatment for: Helicobacter Pylori Infection

Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) is a 3-in-1 capsule triple therapy indicated for the eradication of Helicobacter pylori, a bacterium now recognized as being the main cause of gastric and duodenal ulcers.

• Pylera Axcan Pharma Inc. - Treatment for Eradication of Helicobacter pylori
• Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) FDA Approval History

Yaz (drospirenone and ethinyl estradiol) Tablets

Date of Approval: March 16, 2006
Company: Berlex, Inc.
Treatment for: Acne, Birth Control, Premenstrual Dysphoric Disorder

Yaz (drospirenone and ethinyl estradiol) is a combination oral contraceptive indicated for prevention of pregnancy in women who elect to use an oral contraceptive, treatment of symptoms of premenstrual dysphoric disorder and for the treatment of moderate acne vulgaris.

• Yaz Acne - Treatment for Prevention of Pregnancy, Premenstrual Dysphoric Disorder
• Yaz (drospirenone and ethinyl estradiol) FDA Approval History

Brovana (arformoterol tartrate) Inhalation Solution

Date of Approval: October 6, 2006
Company: Sepracor Inc.
Treatment for: COPD

Brovana (arformoterol tartrate) is a long-acting beta2-agonist for inhalation via a nebulizer, used for the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

• Brovana Sepracor Inc. - Treatment for Chronic Obstructive Pulmonary Disease
• Brovana (arformoterol tartrate) FDA Approval History

Zolinza (vorinostat) Capsules

Date of Approval: October 6, 2006
Company: Merck & Co., Inc.
Treatment for: Cutaneous T-cell Lymphoma

Zolinza (vorinostat) is a histone deacetylase (HDAC) inhibitor for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin's lymphoma, who have progressive, persistent or recurrent disease on or following two systemic therapies.

• Zolinza Merck & Co., Inc. - Treatment for Cutaneous T-cell Lymphoma
• Zolinza (vorinostat) FDA Approval History

Januvia (sitagliptin phosphate) Tablets

Date of Approval: October 17, 2006
Company: Merck & Co., Inc.
Treatment for: Type 2 Diabetes

Januvia (sitagliptin phosphate) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

• Januvia Merck & Co., Inc. - Treatment for Type 2 Diabetes
• Januvia (sitagliptin phosphate) FDA Approval History

Desonate (desonide) Gel

Date of Approval: October 20, 2006
Company: SkinMedica, Inc.
Treatment for: Dermatitis

Desonate (desonide) is a low potency topical steroid formulated in a proprietary water- based Hydrogel vehicle indicated for the treatment of mild to moderate atopic dermatitis.

• Desonate SkinMedica, Inc. - Treatment for Atopic Dermatitis
• Desonate (desonide) FDA Approval History

Omnaris (ciclesonide) Nasal Spray

Date of Approval: October 20, 2006
Company: Altana Pharma
Treatment for: Allergic Rhinitis

Omnaris (ciclesonide) is an intranasal corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 12 years of age and older.

• Omnaris Altana Pharma - Treatment for Allergic Rhinitis
• Omnaris (ciclesonide) FDA Approval History

Tyzeka (telbivudine) Tablets

Date of Approval: October 25, 2006
Company: Novartis
Treatment for: Hepatitis B

Marketing Status: Discontinued

Tyzeka (telbivudine) is a synthetic thymidine nucleoside analogue indicated for the treatment of chronic hepatitis B.

• Tyzeka Novartis - Treatment for Chronic Hepatitis B
• Tyzeka (telbivudine) FDA Approval History

Bellafill (dermal filler) Injection - formerly ArteFill

Date of Approval: October 27, 2006
Company: Suneva Medical, Inc.
Treatment for: Facial Wrinkles; Acne Scars

Bellafill is a dermal filler indicated for the correction of nasolabial folds (smile lines) and for the treatment of acne scars.

• FDA Approves ArteFill as the First Non-Resorbable Injectable Wrinkle Filler to Correct Smile Lines
• Bellafill (dermal filler) FDA Approval History

Veregen (kunecatechins) Ointment - formerly Polyphenon E

Date of Approval: October 31, 2006
Company: MediGene AG
Treatment for: Condylomata Acuminata

Veregen(kunecatechins) contains a concentrate of catechines extracted from green tea leaves. Veregen is indicated for the treatment of external genital and perianal warts.

• Polyphenon E MediGene AG - Treatment for Genital and Perianal Warts
• Veregen (kunecatechins) FDA Approval History

NitroMist (nitroglycerin) Lingual Aerosol

Date of Approval: November 2, 2006
Company: NovaDel Pharma
Treatment for: Angina

NitroMist is an oral spray formulation of nitroglycerin indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

• NitroMist NovaDel Pharma - Treatment for Angina Pectoris
• NitroMist (nitroglycerin) FDA Approval History

Ziana (clindamycin phosphate and tretinoin) Gel

Date of Approval: November 7, 2006
Company: Medicis and Dow Pharmaceutical Sciences
Treatment for: Acne

Ziana Gel (clindamycin phosphate and tretinoin) is a topical antibiotic and retinoid combination indicated for the treatment of acne vulgaris in patients 12 years or older.

• Ziana Medicis and Dow Pharmaceutical Sciences - Treatment for Acne
• Ziana (clindamycin phosphate and tretinoin) FDA Approval History

Alaway (ketotifen ophthalmic) Ophthalmic Solution

Date of Approval: December 1, 2006
Company: Bausch Health Companies Inc.
Treatment for: Eye Redness/Itching

Alaway (ketotifen) is an over-the-counter ophthalmic antihistamine indicated for the temporary relief of itchy eyes associated with pollen, ragweed, grass, animal hair and dander.

• Alaway Itchy Eyes - Treatment for Itchy Eyes
• Alaway (ketotifen ophthalmic) FDA Approval History

Cyanokit (hydroxocobalamin) Injection

Date of Approval: December 15, 2006
Company: EMD Pharmaceuticals and Dey, LP
Treatment for: Cyanide Poisoning

Cyanokit contains hydroxocobalamin, an antidote indicated for the treatment of known or suspected cyanide poisoning.

• Cyanokit EMD Pharmaceuticals and Dey, LP - Treatment for Cyanide Poisoning
• Cyanokit (hydroxocobalamin) FDA Approval History

Elestrin (estradiol) Gel - formerly Bio-E-Gel

Date of Approval: December 15, 2006
Company: BioSante Pharmaceuticals, Inc.
Treatment for: Postmenopausal Symptoms

Elestrin is a fast-drying transdermal gel formulation of bio-identical estradiol indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.

• Elestrin BioSante Pharmaceuticals, Inc. - Treatment for Menopausal Vasomotor Symptoms
• Elestrin (estradiol) FDA Approval History

Invega (paliperidone)

Date of Approval: December 19, 2006
Company: Janssen, L.P.
Treatment for: Schizophrenia, Schizoaffective Disorder

Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder.

• Invega Approved By FDA as New Treatment for Schizophrenia
• Invega (paliperidone) FDA Approval History

Radiesse (dermal filler) Dermal Filler

Date of Approval: December 22, 2006
Company: BioForm Medical, Inc
Treatment for: Wrinkle Correction

Radiesse is a cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds.

• Radiesse BioForm Medical, Inc - Treatment for Moderate to Severe Facial Wrinkles
• Radiesse (dermal filler) FDA Approval History

Yaz (drospirenone and ethinyl estradiol) Tablets

Date of Approval: March 16, 2006
Company: Berlex, Inc.
Treatment for: Acne, Birth Control, Premenstrual Dysphoric Disorder

Yaz (drospirenone and ethinyl estradiol) is a combination oral contraceptive indicated for prevention of pregnancy in women who elect to use an oral contraceptive, treatment of symptoms of premenstrual dysphoric disorder and for the treatment of moderate acne vulgaris.

• FDA Approves New Indication for Yaz to Treat Acne
• Yaz (drospirenone and ethinyl estradiol) FDA Approval History

Invega (paliperidone)

Date of Approval: December 19, 2006
Company: Janssen, L.P.
Treatment for: Schizophrenia, Schizoaffective Disorder

Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder.

• FDA Approves Invega for Long-Term Maintenance Treatment ofSchizophrenia
• Invega (paliperidone) FDA Approval History

Sprycel (dasatinib) Tablets

Date of Approval: June 28, 2006
Company: Bristol-Myers Squibb Company
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

• FDA Approves New Sprycel (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
• Sprycel (dasatinib) FDA Approval History

Juvederm (dermal filler) Injectable Gel

Date of Approval: June 2, 2006
Company: AbbVie Inc.
Treatment for: Facial Rejuvenation

Juvéderm hyaluronic acid dermal filler products are used for facial rejuvenation.

• FDA Approves Juvéderm XC Containing Lidocaine to Correct Facial Wrinkles and Folds
• Juvederm (dermal filler) FDA Approval History

Juvederm (dermal filler) Injectable Gel

Date of Approval: June 2, 2006
Company: AbbVie Inc.
Treatment for: Facial Rejuvenation

Juvéderm hyaluronic acid dermal filler products are used for facial rejuvenation.

• FDA Approves Juvéderm Voluma XC to Correct Age-Related Volume Loss in the Cheek Area
• Juvederm (dermal filler) FDA Approval History