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New Drug Approvals Archive - March 2014

March 2014

Aveed (testosterone undecanoate) Intramuscular Injection - formerly Nebido

Date of Approval: March 5, 2014
Company: Endo Pharmaceuticals
Treatment for: Hypogonadism -- Male

Aveed (testosterone undecanoate) is a long-acting androgen depot injection for the treatment of male hypogonadism.

Xartemis XR (acetaminophen and oxycodone hydrochloride) Extended-Release Tablets - formerly MNK-795

Date of Approval: March 11, 2014
Company: Mallinckrodt
Treatment for: Pain

Xartemis XR (acetaminophen and oxycodone hydrochloride) is an extended-release analgesic and opioid agonist formulation for the management of moderate to severe acute pain.

Qudexy XR (topiramate) Extended-Release Capsules

Date of Approval: March 11, 2014
Company: Upsher-Smith Laboratories, Inc.
Treatment for: Seizures, Lennox-Gastaut Syndrome, Migraine Prophylaxis

Qudexy XR (topiramate) is an antiepileptic drug indicated for the treatment of partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in adults and children; and for the prophylaxis of migraine headache in adults and adolescents.

Hemangeol (propranolol hydrochloride) Oral Solution

Date of Approval: March 14, 2014
Company: Pierre Fabre Dermatologie
Treatment for: Infantile Hemangioma

Hemangeol (propranolol hydrochloride) is a pediatric beta-blocker formulation indicated for the treatment of proliferating infantile hemangioma.

Impavido (miltefosine) Capsules

Date of Approval: March 19, 2014
Company: Paladin Labs Inc.
Treatment for: Leishmaniasis

Impavido (miltefosine) is an oral alkylphosphocholine antiparasitic for the treatment of leishmaniasis.

Neuraceq (florbetaben F18) Injection

Date of Approval: March 19, 2014
Company: Piramal Imaging
Treatment for: Positron Emission Tomography Imaging

Neuraceq (florbetaben F18) is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate β-amyloid neuritic plaquedensity in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.

Otezla (apremilast) Tablets

Date of Approval: March 21, 2014
Company: Celgene Corporation
Treatment for: Psoriatic Arthritis, Plaque Psoriasis

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis and plaque psoriasis.

Xolair (omalizumab)

New Indication Approved: March 21, 2014

Topamax (topiramate)

Patient Population Altered: March 28, 2014

Alprolix (coagulation factor IX (recombinant))

Date of Approval: March 28, 2014
Company: Biogen Idec, Inc.
Treatment for: Hemophilia B

Alprolix (coagulation factor IX (recombinant)) is a clotting factor IX therapy indicated to prevent bleeding in patients with hemophilia B.

Nexium (esomeprazole)

New Formulation Approved: March 28, 2014

New Drug Approvals Archive

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