New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

March 2014

March 3

Bydureon (exenatide)

New Dosage Form Approved: March 3, 2014

Bydureon (exenatide) FDA Approval History

March 5

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.

Aveed (testosterone undecanoate) FDA Approval History

March 11

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.

Xartemis XR (acetaminophen and oxycodone hydrochloride) FDA Approval History

March 11

Qudexy XR (topiramate) Extended-Release Capsules

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

Qudexy XR (topiramate) is an antiepileptic drug indicated for the treatment of partial onset seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut Syndrome.

Qudexy XR (topiramate) FDA Approval History

March 14

Noxafil (posaconazole)

New Dosage Form Approved: March 13, 2014

Noxafil (posaconazole) FDA Approval History

March 14

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.

Hemangeol (propranolol hydrochloride) FDA Approval History

March 18

Eliquis (apixaban)

New Indication Approved: March 13, 2014

Eliquis (apixaban) FDA Approval History

March 19

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.

Impavido (miltefosine) FDA Approval History

March 19

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.

Neuraceq (florbetaben F18) FDA Approval History

March 21

Otezla (apremilast) Tablets

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

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

Otezla (apremilast) FDA Approval History

March 21

Xolair (omalizumab)

New Indication Approved: March 21, 2014

March 28

Topamax (topiramate)

Patient Population Altered: March 28, 2014

March 28

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.

Alprolix (coagulation factor IX (recombinant)) FDA Approval History

March 31

Nexium (esomeprazole)

New Formulation Approved: March 28, 2014

Hide
(web3)