Drugs.com - New Drug Approvals

Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol

Thu, 09 Feb 2012 19:02:48 GMT

ST. LOUIS, Feb. 9, 2012 /PRNewswire/ -- Mobius Therapeutics, LLC, a St. Louis-based ophthalmic company, has received final approval from the U.S. Food and Drug Administration for the platform product, Mitosol. This initial indication is for...

Sanofi Announces FDA Approval of Sklice Lotion for the Treatment of Head Lice

Tue, 07 Feb 2012 20:02:45 GMT

BRIDGEWATER, N.J., Feb. 7, 2012 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older....

Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD

Tue, 07 Feb 2012 17:02:32 GMT

PHILADELPHIA, February 7, 2012 /PRNewswire/ -- Vyvanse (lisdexamfetamine dimesylate), an approved treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, is the first medication both proven to work and approved...

FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience

Thu, 02 Feb 2012 19:02:32 GMT

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Feb 2, 2012 - Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved Janumet XR (sitagliptin and metformin hydrochloride (HCl)...

FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes

Wed, 01 Feb 2012 13:02:34 GMT

RIDGEFIELD, Conn., and INDIANAPOLIS, Jan. 30, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin...

FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer

Tue, 31 Jan 2012 23:01:15 GMT

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in...

FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis

Tue, 31 Jan 2012 18:01:18 GMT

TUESDAY, January 31, 2012 -- The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic...

FDA Approves Erivedge for Basal Cell Carcinoma

Mon, 30 Jan 2012 17:01:36 GMT

SILVER SPRING, Md., Jan. 30, 2012 /PRNewswire-USNewswire/ -- Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is...

FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes

Sat, 28 Jan 2012 01:01:54 GMT

SAN DIEGO and DUBLIN, Jan. 27, 2012 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. and Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) – the...

FDA Approves Inlyta for Advanced Renal Cell Carcinoma

Fri, 27 Jan 2012 22:01:37 GMT

FRIDAY, January 27, 2012 -- The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. Renal cell...

FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing

Wed, 25 Jan 2012 19:01:52 GMT

PARSIPPANY, N.J., January 25, 2012, 2012 /PRNewswire/ -- Leo Pharma announced today that the U.S. Food and Drug Administration (FDA) approved Picato (ingenol mebutate) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). AK is...

UCB Announces FDA Approval for Keppra in Infants and Children from One Month of Age with Partial Onset Seizures

Wed, 25 Jan 2012 18:01:31 GMT

ATLANTA--(BUSINESS WIRE)--Jan 25, 2012 - UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of partial onset seizures...

New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease

Wed, 25 Jan 2012 16:01:37 GMT

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 25, 2012 - Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an updated label for...

FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis

Wed, 25 Jan 2012 00:01:23 GMT

FRIDAY, January 20, 2012 - The U.S. Food and Drug Administration today approved Zetonna (ciclesonide) nasal aerosol to treat the symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and...

FDA Approves Subcutaneous Administration of Velcade In All Approved Indications

Tue, 24 Jan 2012 15:01:34 GMT

CAMBRIDGE, Mass., January 23, 2012–Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new...

U.S. Food and Drug Administration Approves New Formulations of Viread for Use by Children Living With HIV

Thu, 19 Jan 2012 12:01:08 GMT

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan 19, 2012 - Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for...

FDA Approves Voraxaze to Treat Patients with Toxic Methotrexate Levels

Wed, 18 Jan 2012 03:01:33 GMT

January 17, 2012 -- The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug...

Seattle Genetics Announces Updates to Adcetris Prescribing Information

Fri, 13 Jan 2012 12:01:21 GMT

BOTHELL, Wash.--(BUSINESS WIRE)--Jan 13, 2012 - Seattle Genetics, Inc. today announced updates to the U.S. Prescribing Information (PI) for Adcetris (brentuximab vedotin). The revised PI will include the following updated information: A...

Insys Therapeutics Announces FDA Approval of Subsys Fentanyl Sublingual Spray

Thu, 05 Jan 2012 15:01:44 GMT

PHOENIX, Jan 5, 2012 - INSYS Therapeutics announces the US Food and Drug Administration approval of its branded breakthrough cancer pain medication, Subsys fentanyl sublingual spray. Subsys is a sublingually-administered formulation of fentanyl...

CSL Behring Receives FDA Approval of Expanded Label on Berinert for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema

Tue, 03 Jan 2012 16:01:06 GMT

Patients with rare, sometimes life-threatening condition can now treat themselves at home at the first sign of acute facial, abdominal or laryngeal swelling attacks KING OF PRUSSIA, Pa., Jan. 3, 2012 /PRNewswire/ -- CSL Behring today announced...

FDA Expands Use of Prevnar 13 Vaccine for People Ages 50 and Older

Tue, 03 Jan 2012 14:01:42 GMT

SILVER SPRING, Md., Dec. 30, 2011 /PRNewswire-USNewswire/ -- Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive...

FDA Expands Use of HIV Drug Isentress to Children and Adolescents

Wed, 21 Dec 2011 20:12:15 GMT

SILVER SPRING, MD., Dec. 21, 2011 /PRNewswire-USNewswire/ -- Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and...

FDA Approves Edarbyclor (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension

Tue, 20 Dec 2011 22:12:17 GMT

DEERFIELD, Ill. and OSAKA, Japan, Dec. 20, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the U.S. Food and Drug Administration...

Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant

Mon, 12 Dec 2011 13:12:37 GMT

CHADDS FORD, Pa., Dec. 12, 2011 /PRNewswire/ -- Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Opana ER designed to be crush-resistant. "FDA's approval of this new...

Anturol Approved by FDA for the Treatment of Overactive Bladder

Thu, 08 Dec 2011 13:12:30 GMT

PARSIPPANY, N.J. and EWING, N.J., Dec. 8, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. and Antares Pharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Anturol topical oxybutynin gel 3% for the...

FDA Approves Intermezzo for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep

Wed, 23 Nov 2011 21:11:31 GMT

November 23, 2011 -- The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. ...

FDA Approves Eylea for Wet Age-Related Macular Degeneration

Fri, 18 Nov 2011 23:11:47 GMT

November 18, 2011 -- The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and...

FDA Approves Erwinaze to Treat Acute Lymphoblastic Leukemia

Fri, 18 Nov 2011 17:11:14 GMT

November 18, 2011 -- The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived...

FDA Approves Jakafi to Treat Myelofibrosis

Wed, 16 Nov 2011 21:11:47 GMT

November 16, 2011 -- The U.S. Food and Drug Administration today approved Jakafi (ruxolitinib), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis. Myelofibrosis is a disease in which the bone marrow...

Merz Aesthetics Announces FDA Approval of Belotero Balance Dermal Filler for the Correction of Moderate-to-Severe Facial Wrinkles and Folds

Wed, 16 Nov 2011 21:11:27 GMT

SAN MATEO, Calif., November 16, 2011 -- Merz Aesthetics today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Belotero Balance for the correction of moderate-to-severe facial wrinkles and folds. Belotero...

IntelGenx Announces FDA Approval of its High Dose Anti-Depressant Forfivo XL

Sat, 12 Nov 2011 00:11:05 GMT

Saint Laurent, Quebec--(November 11, 2011) - IntelGenx Corp. today announced that the U.S. Food and Drug Administration (FDA) has approved Forfivo XL, for patients with Major Depressive Disorder. Forfivo XL is a novel, high-strength formulation of...

FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer

Mon, 07 Nov 2011 19:11:52 GMT

SILVER SPRING, Md., Nov. 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer. Combined with...

FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm

Fri, 04 Nov 2011 19:11:39 GMT

SILVER SPRING, Md., Nov. 4, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm...

Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management

Mon, 31 Oct 2011 17:10:14 GMT

PARSIPPANY, N.J., Oct. 31, 2011 /PRNewswire via COMTEX/ -- Pacira Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved Exparel (bupivacaine liposome injectable suspension) 1.3% for administration into the...

FDA Approves Onfi for Seizures Associated with Lennox-Gastaut Syndrome

Mon, 24 Oct 2011 22:10:28 GMT

October 24, 2011 -- On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older....

Byetta Approved for Use with Insulin Glargine in the U.S.

Thu, 20 Oct 2011 14:10:18 GMT

SAN DIEGO and INDIANAPOLIS, Oct. 19, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved a new use for Byetta (exenatide) injection. Byetta is...

FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body

Fri, 14 Oct 2011 22:10:00 GMT

October 14, 2011 -- The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an...

FDA Approves Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease

Mon, 10 Oct 2011 11:10:32 GMT

RIDGEFIELD, Conn., Oct. 7, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Combivent Respimat, a new, propellant-free inhaler product that uses a...

FDA Approves Combination Therapy Juvisync

Fri, 07 Oct 2011 15:10:11 GMT

SILVER SPRING, Md., Oct. 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously...

FDA Approves Cialis to Treat Benign Prostatic Hyperplasia

Fri, 07 Oct 2011 00:10:13 GMT

October 6, 2011 -- The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH...