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New Drug Approvals Archive - April 2013

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April 2013

April 5

Prolensa (bromfenac) Ophthalmic Solution

Date of Approval: April 5, 2013
Company: Bausch + Lomb
Treatment for: Postoperative Ocular Inflammation

Prolensa (bromfenac ophthalmic solution) is a topical nonsteroidal anti-inflammatory indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Prolensa (bromfenac) FDA Approval History

April 8

Diclegis (doxylamine and pyridoxine) Delayed-Release Tablets

Date of Approval: April 8, 2013
Company: Duchesnay Inc.
Treatment for: Nausea and Vomiting of Pregnancy

Diclegis (doxylamine and pyridoxine) is an antihistamine and vitamin B6 analog combination indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Diclegis (doxylamine and pyridoxine) FDA Approval History

April 15

Topicort (desoximetasone)

New Formulation Approved: April 11, 2013

April 12

Sitavig (acyclovir) Buccal Tablets

Date of Approval: April 12, 2013
Company: BioAlliance Pharma SA
Treatment for: Herpes Simplex Labialis

Sitavig (acyclovir) is a mucoadhesive buccal tablet formulation of the antiviral drug acyclovir indicated for the treatment of recurrent orofacial herpes (cold sores).

Sitavig (acyclovir) FDA Approval History

April 19

Simbrinza (brimonidine and brinzolamide) Ophthalmic Suspension

Date of Approval: April 19, 2013
Company: Alcon
Treatment for: Glaucoma

Simbrinza (brimonidine and brinzolamide) is a fixed combination of an alpha 2 adrenergic receptor agonist and a carbonic anhydrase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Simbrinza (brimonidine and brinzolamide) FDA Approval History

April 23

Amitiza (lubiprostone)

New Indication Approved: April 19, 2013
Treatment for: Chronic Idiopathic Constipation, Opioid-Induced Constipation, Irritable Bowel Syndrome with Constipation

Amitiza (lubiprostone) FDA Approval History

April 29

Kcentra (prothrombin complex concentrate, human)

Date of Approval: April 29, 2013
Company: CSL Behring
Treatment for: Reversal of Vitamin K Antagonist (VKA) Anticoagulation

Kcentra (prothrombin complex concentrate, human) FDA Approval History

April 30

Actemra (tocilizumab)

New Indication Approved: April 30, 2013

Actemra (tocilizumab) FDA Approval History

April 30

Procysbi (cysteamine bitartrate) Delayed-Release Capsules - formerly RP103

Date of Approval: April 30, 2013
Company: Raptor Pharmaceutical Corp.
Treatment for: Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis.

Procysbi (cysteamine bitartrate) FDA Approval History

April 30

Plan B One-Step (levonorgestrel)

Patient Population Altered: April 30, 2013
Treatment for: Emergency Contraception

Plan B One-Step (levonorgestrel) FDA Approval History