New Drug Approvals Archive - April 2013

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.

• Bausch + Lomb Receives FDA Approval for Prolensa

Prolensa (bromfenac) FDA Approval History

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.

• FDA Approves Diclegis for Pregnant Women Experiencing Nausea and Vomiting

Diclegis (doxylamine and pyridoxine) FDA Approval History

Topicort (desoximetasone)

New Formulation Approved: April 11, 2013

• Taro Receives FDA Approval For Topicort (desoximetasone) Topical Spray, 0.25%

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).

• BioAlliance Pharma's Sitavig Receives FDA Approval for the Treatment of Herpes Labialis

Sitavig (acyclovir) FDA Approval History

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.

• Alcon Announces FDA Approval of Simbrinza Suspension, a New Beta Blocker-Free, Fixed-Combination Therapy for Glaucoma Patients

Simbrinza (brimonidine and brinzolamide) FDA Approval History

Amitiza (lubiprostone)

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

• FDA Approves Amitiza for Opioid-Induced Constipation

Amitiza (lubiprostone) FDA Approval History

Kcentra (prothrombin complex concentrate, human)

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

• FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding

Kcentra (prothrombin complex concentrate, human) FDA Approval History

Actemra (tocilizumab)

New Indication Approved: April 30, 2013

• FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis

Actemra (tocilizumab) FDA Approval History

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.

• FDA Approves Procysbi for Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) FDA Approval History

Plan B One-Step (levonorgestrel)

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

• FDA Approves Plan B One-Step Emergency Contraceptive Without a Prescription for Women 15 Years of Age and Older

Plan B One-Step (levonorgestrel) FDA Approval History

Procysbi (cysteamine bitartrate)

Patient Population Altered: August 14, 2015
Treatment for: Nephropathic Cystinosis

• FDA Approves Expanded Label for Procysbi to Treat Children Aged 2-6 Years With Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) FDA Approval History