The Daily Reviewer | Drugs.com - New Drug Approvals

Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults

Mar 10, 2010 4:02am

IRVINE, Calif.--(BUSINESS WIRE)--Mar 10, 2010 - Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) for the treatment of increased muscle stiffness in the elbow, wrist... ...

CSL Behring Receives FDA Approval of Hizentra, First 20 Percent Subcutaneous Immunoglobulin Therapy

Mar 5, 2010 3:54am

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Mar 4, 2010 - CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients... ...

Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment

Mar 3, 2010 6:36am

PRINCETON, N.J., March 3, 2010 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Norditropin FlexPro (somatropin [rDNA origin] injection), a pre-filled injection pen to be used by children... ...

Impax Laboratories Receives Final FDA Approval for Generic Flomax 0.4mg Capsules and Immediately Commences Shipment

Mar 2, 2010 9:03am

HAYWARD, Calif.--(BUSINESS WIRE)--Mar 2, 2010 - Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version... ...

FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets

Mar 2, 2010 4:25am

ST. LOUIS--(BUSINESS WIRE)--Mar 2, 2010 - Covidien today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application 21-217 for Exalgo (hydromorphone HCl) Extended-Release Tablets, (CII). The indication for... ...

Fougera Announces First Generic Approval of Imiquimod Cream 5% (Rx), Equivalent to Aldara

Feb 26, 2010 5:44am

MELVILLE, N.Y., February 25, 2010 /PRNewswire/ -- E. Fougera & Co., a leading specialty pharmaceutical manufacturer, today announced it has received first generic approval from the FDA for Imiquimod Cream 5% (Rx). Fougera's Imiquimod Cream 5% is... ...

FDA Approves VPRIV to Treat Gaucher Disease

Feb 25, 2010 9:00pm

The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease. Gaucher disease occurs in people who do not produce enough of an... ...

FDA Approves Prevnar 13 Pneumococcal Disease Vaccine

Feb 24, 2010 12:36pm

SILVER SPRING, Md., Feb. 24 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be... ...

U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa

Feb 23, 2010 7:50am

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb 23, 2010 - Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston (aztreonam for inhalation solution) as a treatment to... ...

Novartis Gets US Approval for Menveo Meningitis Vaccine

Feb 22, 2010 7:19am

BASEL, Switzerland -- Swiss drug maker Novartis AG said Monday that its meningitis vaccine Menveo has been approved for use in teenagers and adults by the U.S. Food and Drug Administration. Menveo is a vaccine against four common types of... ...

FDA Approves Once-Daily Mirapex ER for the Treatment of Early Parkinson's Disease

Feb 22, 2010 7:12am

RIDGEFIELD, Conn., Feb. 22 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER (pramipexole dihydrochloride) extended-release tablets, a new... ...

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia

Feb 19, 2010 4:35am

ROCKVILLE, Md., Feb. 18, 2010--The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer. Rituxan, an anti-cancer... ...

Abbott Receives U.S. FDA Approval for Heat-Stable Norvir (ritonavir) Tablets

Feb 12, 2010 7:57am

ABBOTT PARK, Ill., Feb. 11 /PRNewswire-FirstCall/ -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir (ritonavir). The new... ...

FDA Approves Benicar for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16

Feb 11, 2010 5:40am

PARSIPPANY, N.J., Feb. 11 /PRNewswire/ -- Daiichi Sankyo, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the hypertension treatment Benicar (olmesartan medoxomil) for use in children and adolescents 6 to 16... ...

FDA Approves Crestor to Reduce Stroke, Heart Attack Risk

Feb 9, 2010 5:06am

Approval based on JUPITER study which evaluated Crestor in a previously unstudied population WILMINGTON, Del., Feb. 8 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Crestor... ...

FDA Approves Once-A-Day Lamictal XR as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures

Feb 5, 2010 11:58am

RESEARCH TRIANGLE PARK, N.C., Jan. 29 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal XR (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy... ...

Labopharm Receives FDA Approval for Oleptro

Feb 3, 2010 7:54am

LAVAL, QC and PRINCETON, NJ, Feb. 3 /PRNewswire-FirstCall/ -- Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Oleptro (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of... ...

Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex for the Treatment of Dupuytren's Contracture

Feb 3, 2010 7:53am

MALVERN, Pa., Feb. 3 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, just announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Xiaflex (collagenase... ...

GSK's Tykerb Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer

Feb 1, 2010 6:04am

PHILADELPHIA, Jan. 29 /PRNewswire/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using Tykerb (lapatinib) as a first-line, all-oral treatment for... ...

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain

Jan 29, 2010 5:43am

Approval is part of Agency's unapproved drugs initiative SILVER SPRING, Md., Jan. 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and... ...

U.S. Food and Drug Administration Approves Labeling Update for Prezista To Include 96-Week Data in HIV-1 Infected Adult Patients

Jan 28, 2010 5:50am

BRIDGEWATER, N.J., Jan. 27 /PRNewswire/ -- Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Prezista (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN... ...

FDA Approves Novo-Nordisk's Diabetes Drug Victoza

Jan 26, 2010 5:53am

WASHINGTON, Jan. 26, 2010 -- U.S. health officials on Monday approved Danish drugmaker Novo Nordisk's once-daily injection for treating type 2 diabetes but said more safety studies are needed before it can be cleared as a first-line treatment... ...

FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis

Jan 21, 2010 9:00pm

The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those... ...

HIV/AIDS Update - Atripla label update reflects new efficacy, safety and resistance data in treatment experienced patients

Jan 11, 2010 12:20pm

ROCKVILLE, Md., Jan 7, 2010-On January 7, 2010, FDA approved an updated Atripla label including new efficacy, safety and resistance data in treatment experienced patients from a trial (Study 073: A Phase IV, Open-Label, Randomized, Multicenter... ...

FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

Jan 11, 2010 6:00am

BASEL, Switzerland, Jan. 11, 2010 - Roche today announced that the United States (US) Food and Drug Administration (FDA) approved Actemra (tocilizumab, RoActemra in the European Union) for the treatment of adult patients with moderately to... ...

FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

Jan 5, 2010 11:15am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 4, 2010 - Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Velcade, which expands the... ...

FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

Dec 22, 2009 9:00pm

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B. People in this age group are at highest... ...

FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations

Dec 18, 2009 4:23am

RIDGEFIELD, Conn. & NEW YORK--(BUSINESS WIRE)--Dec 17, 2009 - Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Spiriva HandiHaler (tiotropium bromide... ...

FDA Approves Newly Revised Prescribing Information for Azilect Reducing Medication and Food Restrictions

Dec 14, 2009 8:13am

JERUSALEM--(BUSINESS WIRE)--Dec 14, 2009 - Teva Pharmaceutical Industries, Ltd. today announced the U.S. Food and Drug Administration (FDA) approved the newly revised prescribing information for Azilect (rasagiline tablets) reducing medication... ...

FDA Approves Lilly's Zyprexa Relprevv for Treatment of Schizophrenia in Adults

Dec 14, 2009 5:45am

INDIANAPOLIS, Dec. 14 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) approved Zyprexa Relprevv (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults, Eli Lilly and Company... ...

Octapharma USA Announces FDA Approval of Wilate - the First Replacement Therapy Developed Specifically for von Willebrand Disease

Dec 8, 2009 12:22pm

HOBOKEN, N.J., Dec. 7 /PRNewswire/ -- Octapharma USA today announced the U.S. Food and Drug Administration has approved Wilate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von... ...

Tris Pharma Announces Two NDA Approvals from FDA including a Pioneering, First-Ever 24 hour Liquid Sustained Release Product

Dec 7, 2009 1:10pm

SOUTH BRUNSWICK, N.J., Dec. 7; /PRNewswire/ -- Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved its first two New... ...

Amneal Receives FDA Approval for Nizatidine Oral Solution, the First Generic Oral Solution for Axid in the Market

Dec 7, 2009 11:15am

HAUPPAUGE, N.Y.--(BUSINESS WIRE)--Dec 3, 2009 - Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an... ...

FDA Approves Lilly's Zyprexa for Two Adolescent Indications

Dec 7, 2009 7:53am

INDIANAPOLIS, Dec. 4 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today approved Zyprexa (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I... ...

FDA Approves Seroquel XR For Add-On Treatment of Major Depressive Disorder

Dec 4, 2009 12:15pm

WILMINGTON, Del., Dec. 4 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Seroquel XR (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to... ...

Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older

Dec 2, 2009 8:38am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 1, 2009 - Dyax Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for Kalbitor (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in... ...

FDA Approves 10 mcg Dose of Vagifem for the Treatment of Atrophic Vaginitis Due to Menopause

Dec 2, 2009 6:31am

PRINCETON, N.J., Dec. 2 /PRNewswire-FirstCall/ -- Novo Nordisk said today that the U.S. Food and Drug Administration (FDA) has approved a 10 mcg dose formulation of Vagifem (estradiol vaginal tablets) for the treatment of atrophic vaginitis due... ...

Reports of FDA and international regulatory bodies' approvals of drugs currently in development.

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