New Drug Approvals

New Drug Approvals

The following drugs have recently been approved by the FDA.
Qutenza (capsaicin) Transdermal Patch
Date of Approval: November 16, 2009
Treatment for: Postherpetic Neuralgia
Qutenza Drug Information | Press Release

Lysteda (tranexamic acid) Tablets
Date of Approval: November 13, 2009
Treatment for: Menorrhagia
Lysteda Drug Information | Press Release

Istodax (romidepsin) for Injection
Date of Approval: November 5, 2009
Treatment for: Cutaneous T-cell Lymphoma
Istodax Drug Information | Press Release

Pennsaid (diclofenac sodium) Topical Solution
Date of Approval: November 4, 2009
Treatment for: Osteoarthritis
Pennsaid 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.
Abilify (aripiprazole)
New Indication Approved: November 19, 2009
Now Approved for: Irritability Associated with Autistic Disorder in
Pediatric Patients
Abilify Drug Information | Press Release

Byetta (exenatide) Injection
New Indication Approved: November 2, 2009
Now Approved for: Type 2 Diabetes Monotherapy
Byetta Drug Information | Press Release

Influenza A (H1N1) 2009 Monovalent Vaccine
Patient Population Altered: November 10, 2009
Now Approved for: Childen 6 Months and Older
Influenza A (H1N1) 2009 Monovalent Vaccine 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.
Buprenorphine Hydrochloride
Sublingual Tablets 2 mg (base) and 8 mg (base)
Approved: October 8, 2009 Roxane Laboratories, Inc.
Generic for: Subutex

Chlorothiazide Sodium
for Injection, USP 500 mg (base)/vial
Approved: October 16, 2009 APP Pharmaceuticals, Inc.
Generic for: Diuril for Injection

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