New Drug Approvals Archive - June 2015

Qudexy XR (topiramate)

Patient Population Altered: March 31, 2015

• FDA Approves Expanded Indication for Qudexy XR (Topiramate) for Pediatric Patients

Qudexy XR (topiramate) FDA Approval History

Promacta (eltrombopag)

Patient Population Altered: June 12, 2015

• FDA Approves Promacta for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication

Promacta (eltrombopag) FDA Approval History

Zomig Nasal Spray (zolmitriptan)

Patient Population Altered: June 12, 2015

• FDA Approves Zomig (zolmitriptan) Nasal Spray for Migraine in Pediatric Patients (Ages 12-17)

Kengreal (cangrelor) for Injection

Date of Approval: June 22, 2015
Company: The Medicines Company
Treatment for: Percutaneous Coronary Intervention

Kengreal (cangrelor) is an intravenous P2Y₁₂ platelet inhibitor indicated for use in patients undergoing Percutaneous Coronary Intervention (PCI) to reduce the risk of periprocedural thrombotic events.

• FDA Approves Antiplatelet Agent Kengreal (cangrelor) as Adjunct to Percutaneous Coronary Intervention

Kengreal (cangrelor) FDA Approval History

Fycompa (perampanel)

New Indication Approved: June 19, 2015

• FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures

Fycompa (perampanel) FDA Approval History

Tuxarin ER (chlorpheniramine and codeine)

Date of Approval: June 22, 2015
Company: Spriaso LLC
Treatment for: Cough, Cold Symptoms

Tuxarin ER (codeine and chlorpheniramine) is a long acting narcotic antitussive and antihistamine combination for the treatment of cough and cold symptoms.

• Spriaso Announces FDA Approval of Long Acting Tuxarin ER (codeine and chlorpheniramine)

Tuxarin ER (chlorpheniramine and codeine) FDA Approval History