New Drug Approvals Archive

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July 2009

July 1

Multaq (dronedarone) Tablets

Date of Approval: July 1, 2009
Company: Sanofi-aventis
Treatment for: Atrial Fibrillation, Atrial Flutter

Multaq (dronedarone) is antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter.

Multaq (dronedarone) FDA Approval History

July 7

Alimta (pemetrexed)

New Indication Approved: July 2, 2009

Alimta (pemetrexed) FDA Approval History

July 10

Effient (prasugrel) Tablets

Date of Approval: July 10, 2009
Company: Daiichi Sankyo Company, Limited and Eli Lilly and Company
Treatment for: Acute Coronary Syndrome

Effient (prasugrel) is an oral antiplatelet agent for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention including coronary stenting.

Effient (prasugrel) FDA Approval History

July 10

Plan B One-Step (levonorgestrel) Tablet

Date of Approval: July 10, 2009
Company: Teva Pharmaceuticals, Inc.
Treatment for: Emergency Contraception

Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure.

Plan B One-Step (levonorgestrel) FDA Approval History

July 15

Sumavel DosePro (sumatriptan) Injection

Date of Approval: July 15, 2009
Company: Zogenix, Inc.
Treatment for: Migraine, Cluster Headache

Sumavel DosePro (sumatriptan injection) is a needle-free delivery system to treat acute migraine, with or without aura, and cluster headache.

Sumavel DosePro (sumatriptan) FDA Approval History

July 16

Onsolis (fentanyl) Buccal Soluble Film - formerly BEMA Fentanyl

Date of Approval: July 16, 2009
Company: BioDelivery Sciences International, Inc.
Treatment for: Pain

Onsolis consists of a dissolvable polymer film formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek). Onsolis is used for the management of breakthrough pain in patients with cancer.

Onsolis (fentanyl) FDA Approval History

July 20

NovoLog (insulin aspart)

Expiration Date Change Approved: July 14, 2009

July 21

Tekturna HCT (aliskiren and hydrochlorothiazide)

New Indication Approved: July 16, 2009

Tekturna HCT (aliskiren and hydrochlorothiazide) FDA Approval History

July 22

Acuvail (ketorolac tromethamine) Ophthalmic Solution

Date of Approval: July 22, 2009
Company: Allergan, Inc.
Treatment for: Postoperative Ocular Inflammation

Acuvail (ketorolac tromethamine) is a preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.

Acuvail (ketorolac tromethamine) FDA Approval History

July 23

Forteo (teriparatide (rDNA origin))

New Indication Approved: July 22, 2009

July 29

Sculptra (injectable poly-L-lactic acid)

New Formulation Approved: July 29, 2009
Treatment for: Facial Lipoatrophy; Facial Wrinkles

Sculptra (injectable poly-L-lactic acid) FDA Approval History

July 30

Tyvaso (treprostinil) Inhalation Solution

Date of Approval: July 30, 2009
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension

Tyvaso (treprostinil) is an inhaled prostanoid analogue indicated for the treatment of pulmonary arterial hypertension.

Tyvaso (treprostinil) FDA Approval History

July 29

Colcrys (colchicine) Tablets

Date of Approval: July 29, 2009
Company: Mutual Pharmaceutical Company, Inc.
Treatment for: Gout, Familial Mediterranean Fever, Gout -- Prophylaxis, Acute Gout

Colcrys (colchicine) is compound derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale). Colcrys is approved for the prophylaxis and treatment of acute gout flares, and for the treatment of patients with familial Mediterranean fever.

Colcrys (colchicine) FDA Approval History

July 31

Onglyza (saxagliptin) Tablets

Date of Approval: July 31, 2009
Company: Bristol-Myers Squibb Company and AstraZeneca
Treatment for: Diabetes Type 2

Onglyza (saxagliptin) is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated for the treatment of type 2 diabetes mellitus in adults.

Onglyza (saxagliptin) FDA Approval History

July 31

Xerese (acyclovir and hydrocortisone) Topical Cream - formerly Lipsovir

Date of Approval: July 31, 2009
Company: Meda Pharmaceuticals Inc.
Treatment for: Herpes Simplex Labialis

Xerese (acyclovir and hydrocortisone) is a topical antiviral and anti-inflammatory combination for the prevention and treatment of cold sores.

Xerese (acyclovir and hydrocortisone) FDA Approval History

October 22

Colcrys (colchicine)

New Indication Approved: October 16, 2009

Colcrys (colchicine) 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

June 20

Plan B One-Step (levonorgestrel)

Patient Population Altered: June 20, 2013
Treatment for: Emergency Contraception

Plan B One-Step (levonorgestrel) FDA Approval History

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