New Drug Approvals Archive - July 2009

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.

• FDA Approves Multaq for Patients with Atrial Fibrillation or Atrial Flutter

Multaq (dronedarone) FDA Approval History

Alimta (pemetrexed)

New Indication Approved: July 2, 2009

• Lilly Receives Fourth FDA Approval for Alimta (pemetrexed for injection) as Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer

Alimta (pemetrexed) FDA Approval History

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.

• Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient

Effient (prasugrel) FDA Approval History

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.

• FDA Approves Plan B One-Step, a New One-Pill Emergency Contraceptive

Plan B One-Step (levonorgestrel) FDA Approval History

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 injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System

Sumavel DosePro (sumatriptan) FDA Approval History

Onsolis (fentanyl) Buccal Soluble Film - formerly BEMA Fentanyl

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

Onsolis (fentanyl) is an opioid agonist in a buccal formulation indicated for the management of breakthrough pain in cancer patients.

• BioDelivery Sciences and Meda Announce FDA Approval of Onsolis

Onsolis (fentanyl) FDA Approval History

NovoLog (insulin aspart)

Expiration Date Change Approved: July 14, 2009

• FDA Approves NovoLog Labeling Update

Tekturna HCT (aliskiren and hydrochlorothiazide)

New Indication Approved: July 16, 2009

• FDA Approves Tekturna HCT as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

Tekturna HCT (aliskiren and hydrochlorothiazide) FDA Approval History

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.

• Allergan Receives FDA Approval for Acuvail Ophthalmic Solution for the Treatment of Pain and Inflammation Following Cataract Surgery

Acuvail (ketorolac tromethamine) FDA Approval History

Forteo (teriparatide (rDNA origin))

New Indication Approved: July 22, 2009

• FDA Approves Expanded Use of Lilly's Forteo [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis

Sculptra (injectable poly-L-lactic acid)

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

• FDA Approves Sculptra Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles

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

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.

• FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension

Tyvaso (treprostinil) FDA Approval History

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.

• FDA Approves Colcrys (colchicine) for Acute Gout, Mediterranean Fever

Colcrys (colchicine) FDA Approval History

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.

• FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes

Onglyza (saxagliptin) FDA Approval History

Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension

Date of Approval: July 31, 2009
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Schizophrenia, Schizoaffective Disorder

Invega Sustenna (1-month paliperidone palmitate) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia and schizoaffective disorder.

• FDA Approves Invega Sustenna for the Acute and Maintenance Treatment of Schizophrenia

Invega Sustenna (paliperidone palmitate) FDA Approval History

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.

• The US FDA approves Lipsovir for marketing and sales in US

Xerese (acyclovir and hydrocortisone) FDA Approval History

Colcrys (colchicine)

New Indication Approved: October 16, 2009

• FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares

Colcrys (colchicine) 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

Plan B One-Step (levonorgestrel)

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

• FDA Approves Plan B One-Step Emergency Contraceptive For Use Without A Prescription For All Women Of Child-Bearing Potential

Plan B One-Step (levonorgestrel) FDA Approval History

Invega Sustenna (paliperidone palmitate)

New Indication Approved: November 13, 2014

• FDA Approves sNDA for Invega Sustenna (paliperidone palmitate) for Schizoaffective Disorder

Invega Sustenna (paliperidone palmitate) FDA Approval History

Onsolis (fentanyl)

New Formulation Approved: August 11, 2015

• BioDelivery Sciences Announces FDA Approval of New Formulation of Onsolis (fentanyl buccal soluble film) CII

Onsolis (fentanyl) FDA Approval History