Pharmaceutical News and Articles

New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, New Drug Applications, Recent Additions to Drugs.com, Approval Process, New Indications and Dosage forms

Latest New Drug Approvals


Pennsaid (diclofenac sodium) Topical Solution

Date of Approval: November 5, 2009

Company: Nuvo Research Inc.

Treatment for: Osteoarthritis

Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.


Istodax (romidepsin) for Injection

Date of Approval: November 5, 2009

Company: Gloucester Pharmaceuticals

Treatment for: Cutaneous T-cell Lymphoma

Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma.


Arzerra (ofatumumab) Injection

Date of Approval: October 26, 2009

Company: GlaxoSmithKline

Treatment for: Chronic Lymphocytic Leukemia

Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.


Votrient (pazopanib) Tablets

Date of Approval: October 19, 2009

Company: GlaxoSmithKline

Treatment for: Renal Cell Carcinoma

Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.


Twynsta (telmisartan and amlodipine) Tablets

Date of Approval: October 16, 2009

Company: Boehringer Ingelheim Pharmaceuticals Inc.

Treatment for: Hypertension

Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents.


Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) Injection

Date of Approval: October 16, 2009

Company: GlaxoSmithKline

Treatment for: Human Papillomavirus Prophylaxis

Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).


Berinert (C1 esterase inhibitor (human)) Injection

Date of Approval: October 9, 2009

Company: CSL Behring

Treatment for: Angioedema

Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.


Stelara (ustekinumab) Injection

Date of Approval: September 25, 2009

Company: Centocor Ortho Biotech Inc.

Treatment for: Psoriasis

Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis.


Folotyn (pralatrexate) Injection

Date of Approval: September 24, 2009

Company: Allos Therapeutics, Inc.

Treatment for: Peripheral T-cell Lymphoma

Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).


Valturna (aliskiren and valsartan) Tablets

Date of Approval: September 16, 2009

Company: Novartis

Treatment for: Hypertension

Valturna is a combination of aliskiren (a direct renin inhibitor) and valsartan (an angiotensin II receptor blocker) indicated for the treatment of high blood pressure.


Zirgan (ganciclovir) Ophthalmic Gel

Date of Approval: September 15, 2009

Company: Sirion Therapeutics, Inc.

Treatment for: Herpetic Keratitis

Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).


Date of Approval: September 15, 2009

Company: CSL Limited; Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc.; MedImmune LLC

Treatment for: Prevention of H1N1 Influenza

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.


Vibativ (telavancin) Injection

Date of Approval: September 11, 2009

Company: Theravance Inc.

Treatment for: Complicated Skin and Skin Structure Infections (cSSSI)

Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.


Bepreve (bepotastine) Ophthalmic Solution

Date of Approval: September 8, 2009

Company: ISTA Pharmaceuticals, Inc.

Treatment for: Allergic Conjunctivitis

Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer for treatment of the symptoms of allergic conjunctivitis.


Metozolv ODT (metoclopramide) Orally Disintegrating Tablets

Date of Approval: September 4, 2009

Company: Salix Pharmaceuticals, Ltd.

Treatment for: Gastroesophageal Reflux Disease, Gastroparesis

Metozolv ODT is a fast–dissolving formulation of metoclopramide for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.


Intuniv (guanfacine) Extended Release Tablets - formerly Connexyn

Date of Approval: September 2, 2009

Company: Shire plc

Treatment for: Attention-Deficit Hyperactivity Disorder

Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).


Zenpep (pancrelipase) Capsules - formerly Zentase

Date of Approval: August 27, 2009

Company: Eurand Pharmaceuticals Ltd.

Treatment for: Pancreatic Exocrine Dysfunction

Zenpep (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.


Sabril (vigabatrin) Tablets and Oral Solution

Date of Approval: August 21, 2009

Company: Lundbeck Inc.

Treatment for: Epilepsy, Seizures

Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of Infantile Spasms and refractory complex partial seizures.


Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection

Date of Approval: August 19, 2009

Company: GlaxoSmithKline

Treatment for: Haemophilus influenzae Prophylaxis

Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children 15 months through 4 years of age (prior to fifth birthday).


Extavia (interferon beta-1b)

Date of Approval: August 14, 2009

Treatment for: Multiple Sclerosis

Extavia is a branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for multiple sclerosis for many years. Extavia is indicated for the treatment of MS patients with relapsing forms of the disease and for newly diagnosed patients.

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FDA Drug Approvals Archive

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