New Drug Approvals Archive
New Indication Approved: November 2, 2009
Pennsaid (diclofenac sodium) Topical Solution
Date of Approval: November 4, 2009
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
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma.
Reyataz (atazanavir sulfate)
Labeling Revision Approved: November 5, 2009
Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine)
Patient Population Altered: November 10, 2009
Lysteda (tranexamic acid) Tablets - formerly XP12B
Date of Approval: November 13, 2009
Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.
Qutenza (capsaicin) Transdermal Patch - formerly NGX-4010
Date of Approval: November 16, 2009
Qutenza, formerly NGX-4010, is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.
Revatio (sildenafil citrate)
New Dosage Form Approved: November 18, 2009
New Indication Approved: November 19, 2009
Agriflu (influenza virus vaccine, inactivated) Injection
Date of Approval: November 27, 2009
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.
New Indication Approved: November 30, 2009
New Indication Approved: June 16, 2011