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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

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Xulane (ethinyl estradiol and norelgestromin) Transdermal System

Company: Mylan Inc.
Date of Approval: April 16, 2014
Treatment for: Contraception

Xulane (ethinyl estradiol and norelgestromin transermal system) is a generic version of Ortho Evra, a birth control patch used to prevent pregnancy.

Xulane FDA Approval History

Tanzeum (albiglutide)

Company: GlaxoSmithKline (GSK) plc
Date of Approval: April 15, 2014
Treatment for: Diabetes Type 2

Tanzeum (albiglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.

Tanzeum FDA Approval History

Evzio (naloxone hydrochloride)

Company: Kaleo Inc.
Date of Approval: April 3, 2014
Treatment for: Opioid Overdose

Evzio (naloxone hydrochloride) is an opioid antagonist hand-held auto-injector indicated for the emergency treatment of known or suspected opioid overdose.

Evzio FDA Approval History

Alprolix (coagulation factor IX (recombinant))

Date of Approval: March 28, 2014
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 FDA Approval History

Otezla (apremilast) Tablets

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

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

Otezla FDA Approval History

Impavido (miltefosine) Capsules

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

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

Impavido FDA Approval History

Neuraceq (florbetaben F18) Injection

Company: Piramal Imaging
Date of Approval: March 19, 2014
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 FDA Approval History

Hemangeol (propranolol hydrochloride) Oral Solution

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

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

Hemangeol FDA Approval History

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

Company: Mallinckrodt
Date of Approval: March 11, 2014
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 FDA Approval History

Qudexy XR (topiramate) Extended-Release Capsules

Company: Upsher-Smith Laboratories, Inc.
Date of Approval: March 11, 2014
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 FDA Approval History

Myalept (metreleptin) Injection

Company: Amylin Pharmaceuticals, Inc.
Date of Approval: February 24, 2014
Treatment for: Lipodystrophy

Myalept (metreleptin) is a leptin analog indicated to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Myalept FDA Approval History

Tivorbex (indomethacin) Capsules

Company: Iroko Pharmaceuticals, LLC
Date of Approval: February 24, 2014
Treatment for: Pain

Tivorbex (indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain.

Tivorbex FDA Approval History

Monovisc (sodium hyaluronate) Injection

Company: Anika Therapeutics, Inc.
Date of Approval: February 24, 2014
Treatment for: Osteoarthritis

Monovisc (sodium hyaluronate) is a viscoelastic supplement indicated for the treatment of pain associated with osteoarthritis of the knee.

Monovisc FDA Approval History

Northera (droxidopa) Capsules

Company: Chelsea Therapeutics International, Ltd.
Date of Approval: February 18, 2014
Treatment for: Neurogenic Orthostatic Hypotension

Northera (droxidopa) is an orally active synthetic precursor of norepinephrine indicated for the treatment of neurogenic orthostatic hypotension.

Northera FDA Approval History

Vimizim (elosufase alfa) Injection

Company: BioMarin Pharmaceutical Inc.
Date of Approval: February 14, 2014
Treatment for: Mucopolysaccharidosis Type IVA

Vimizim (elosufase alfa) is an enzyme replacement therapy for patients with Mucopolysaccharidosis Type IVA (Morquio A syndrome).

Vimizim FDA Approval History

Hetlioz (tasimelteon) Capsules

Company: Vanda Pharmaceuticals Inc.
Date of Approval: January 31, 2014
Treatment for: Non-24-Hour Disorder

Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in the totally blind.

Hetlioz FDA Approval History

Tretten (coagulation factor XIII A-subunit (recombinant))

Company: Novo Nordisk A/S
Date of Approval: December 23, 2013
Treatment for: Factor XIII A-Subunit Deficiency

Tretten (coagulation factor XIII A-subunit (recombinant)) is a recombinant analogue of the human Factor XIII A-subunit for the prevention of bleeding in patients who have the rare clotting disorder congenital Factor XIII A-subunit deficiency.

Tretten FDA Approval History

Orenitram (treprostinil) Extended-Release Tablets

Company: United Therapeutics Corporation
Date of Approval: December 20, 2013
Treatment for: Pulmonary Hypertension

Orenitram (treprostinil extended-release) is an oral prostacyclin for the treatment of pulmonary arterial hypertension.

Orenitram FDA Approval History