New Drug Approvals

New Drug Approvals

The following drugs have recently been approved by the FDA.
Zyclara (imiquimod) Cream
Date of Approval: March 25, 2010
Treatment for: Actinic Keratosis
Zyclara Drug Information | Press Release

Silenor (doxepin) Tablets
Date of Approval: March 17, 2010
Treatment for: Insomnia
Silenor Drug Information | Press Release

Carbaglu (carglumic acid) Tablets
Date of Approval: March 18, 2010
Treatment for: NAGS Deficiency Hyperammonemia
Carbaglu Drug Information | Press Release

Hizentra (immune globulin subcutaneous (human)) Liquid
Date of Approval: March 4, 2010
Treatment for: Primary Immunodeficiency Syndrome
Hizentra Drug Information | Press Release

Exalgo (hydromorphone) Extended Release Tablets
Date of Approval: March 1, 2010
Treatment for: Pain in Opioid Tolerant Patients
Exalgo Drug Information | Press Release

New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional
diseases/conditions or new dosage forms/regimens.
Norditropin (somatropin [rDNA origin]) Injection
New Dosage Form Approved: March 1, 2010
Now Approved: Norditropin FlexPro
Norditropin Drug Information | Press Release

Dacogen (decitabine) for Injection
New Dosage Regimen: March 11, 2010
Now Approved: Five-Day Dosing Regimen
Dacogen Drug Information | Press Release

Differin (adapalene)
New Formulation Approved: March 17, 2010
Now Approved: Differin Lotion
Differin Drug Information | Press Release

Trelstar (triptorelin pamoate) Injection
New Formulation Approved: March 10, 2010
Now Approved: Trelstar 22.5 mg 6-Month Formulation
Trelstar Drug Information | Press Release

Xifaxan (rifaximin) Tablets
New Indication Approved: March 24, 2010
Now Approved for: Hepatic Encephalopathy
Xifaxan Drug Information | Press Release

Mirapex (pramipexole dihydrochloride)
New Indication Approved: March 19, 2010
Now Approved: Mirapex ER for Both Early and Advanced Parkinson's Disease
Mirapex Drug Information | Press Release

Botox (onabotulinumtoxinA) Injection
New Indication Approved: March 9, 2010
Now Approved for: Upper Limb Spasticity
Botox Drug Information | Press Release

First-Time Generic Approvals
First Time Generics are those drug products that have never been
approved before as generic drug products and are new generic products
to the marketplace.
Desloratadine Tablets 5 mg
Approved: February 19, 2010 Company: Orchid Healthcare
Generic for: Clarinex Tablets

Imiquimod Cream 5%
Approved: February 25, 2010 Company: Nycomed US, Inc.
Generic for: Aldara Cream

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