New Drug Approvals Archive

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November 2009

November 2

Byetta (exenatide)

New Indication Approved: November 2, 2009

Byetta (exenatide) FDA Approval History

November 4

Pennsaid (diclofenac sodium) Topical Solution

Date of Approval: November 4, 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.

Pennsaid (diclofenac sodium) FDA Approval History

November 5

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 and peripheral T-cell lymphoma.

Istodax (romidepsin) FDA Approval History

November 6

Reyataz (atazanavir sulfate)

Labeling Revision Approved: November 5, 2009

November 13

Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine)

Patient Population Altered: November 10, 2009
Treatment for: Prevention of H1N1 Influenza

Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine) FDA Approval History

November 13

Lysteda (tranexamic acid) Tablets - formerly XP12B

Date of Approval: November 13, 2009
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Menorrhagia

Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.

Lysteda (tranexamic acid) FDA Approval History

November 16

Qutenza (capsaicin) Transdermal Patch - formerly NGX-4010

Date of Approval: November 16, 2009
Company: NeurogesX, Inc.
Treatment for: Postherpetic Neuralgia

Qutenza, formerly NGX-4010, is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.

Qutenza (capsaicin) FDA Approval History

November 20

Revatio (sildenafil citrate)

New Dosage Form Approved: November 18, 2009

Revatio (sildenafil citrate) FDA Approval History

November 22

Abilify (aripiprazole)

New Indication Approved: November 19, 2009

November 27

Agriflu (influenza virus vaccine, inactivated) Injection

Date of Approval: November 27, 2009
Company: Novartis Vaccines and Diagnostics, Inc.
Treatment for: Influenza Prophylaxis

Agriflu (influenza virus vaccine, inactivated) is a vaccine indicated for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

Agriflu (influenza virus vaccine, inactivated) FDA Approval History

November 30

Cymbalta (duloxetine)

New Indication Approved: November 30, 2009

Cymbalta (duloxetine) FDA Approval History

June 17

Istodax (romidepsin)

New Indication Approved: June 16, 2011

Istodax (romidepsin) FDA Approval History

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