New Drug Approvals Archive - October 2007

Symlin (pramlintide acetate)

New Dosage Form Approved: September 25, 2007

• FDA Approves Symlin Pen-Injector Devices Offering Convenience andAccuracy for Symlin Use
• Symlin (pramlintide acetate) FDA Approval History

Taxotere (docetaxel)

New Indication Approved: September 28, 2007

• Taxotere (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery

Isentress (raltegravir) Tablets

Date of Approval: October 12, 2007
Company: Merck & Co., Inc.
Treatment for: HIV Infection

Isentress (raltegravir) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

• FDA Approves of Isentress (raltegravir)
• Isentress (raltegravir) FDA Approval History

Velcade (bortezomib)

Patient Population Altered: October 10, 2007

• FDA Expands Velcade (Bortezomib) for Injection Label for Patients with Multiple Myeloma

Doribax (doripenem) Injection - formerly Doripenem

Date of Approval: October 12, 2007
Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatment for: Intraabdominal Infection, Urinary Tract Infection

Doribax (doripenem) is a penem antibacterial indicated for the treatment of complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis.

• FDA Approves Doribax for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
• Doribax (doripenem) FDA Approval History

Ixempra (ixabepilone) Injection

Date of Approval: October 16, 2007
Company: Bristol-Myers Squibb
Treatment for: Breast Cancer

Ixempra (ixabepilone) is a semisynthetic analog of epothilone B indicated for the treatment of patients with metastatic or locally advanced breast cancer.

• FDA Approves Ixempra (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
• Ixempra (ixabepilone) FDA Approval History

Voltaren Gel (diclofenac sodium) Topical Gel

Date of Approval: October 17, 2007
Company: Novartis AG
Treatment for: Osteoarthritis

Voltaren Gel (diclofenac sodium) is a topical gel non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.

• Voltaren Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
• Voltaren Gel (diclofenac sodium) FDA Approval History

Renvela (sevelamer carbonate) Tablets

Date of Approval: October 19, 2007
Company: Genzyme Corporation
Treatment for: Hyperphosphatemia of Renal Failure

Renvela (sevelamer carbonate) is a calcium-free, metal-free, non-absorbed phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

• FDA Approves Genzyme's Renvela for Dialysis Patients
• Renvela (sevelamer carbonate) FDA Approval History

Tasigna (nilotinib) Capsules

Date of Approval: October 29, 2007
Company: Novartis
Treatment for: Chronic Myelogenous Leukemia

Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML).

• Tasigna Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients with Resistance or Intolerance to Existing Therapies
• Tasigna (nilotinib) FDA Approval History

Combigan (brimonidine tartrate and timolol maleate) Ophthalmic Solution

Date of Approval: October 30, 2007
Company: Allergan Inc.
Treatment for: Intraocular Hypertension, Glaucoma

Combigan (brimonidine tartrate and timolol maleate) is an alpha adrenergic receptor agonist and beta adrenergic receptor inhibitor combination ophthalmic solution for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.

• Allergan, Inc. Receives FDA Approval for Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
• Combigan (brimonidine tartrate and timolol maleate) FDA Approval History

Isentress (raltegravir)

Labeling Revision Approved: January 29, 2009

• HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)
• Isentress (raltegravir) FDA Approval History

Tasigna (nilotinib)

New Indication Approved: June 17, 2010

• Novartis International AG (CH) - FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec
• Tasigna (nilotinib) FDA Approval History

Isentress (raltegravir)

Patient Population Altered: December 21, 2011

• FDA Expands Use of HIV Drug Isentress to Children and Adolescents
• Isentress (raltegravir) FDA Approval History

Isentress (raltegravir)

Labeling Revision Approved: June 28, 2013

• FDA Approves New U.S. Labeling for Isentress (raltegravir) to Include 240-Week Results from STARTMRK Study of Isentress Containing Regimen in Previously Untreated HIV-1 Infected Adult Patient
• Isentress (raltegravir) FDA Approval History

Isentress (raltegravir)

New Dosage Form Approved: May 26, 2017

• Merck Receives FDA Approval of Isentress HD (raltegravir), a New Once-Daily Option for the Combination Treatment of HIV-1 Infection in Appropriate Patients
• Isentress (raltegravir) FDA Approval History

Isentress (raltegravir)

Patient Population Altered: November 22, 2017

• Merck Receives FDA Approval for Isentress (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Newborns Weighing at Least 2 kg
• Isentress (raltegravir) FDA Approval History

Tasigna (nilotinib)

New Dosage Regimen: December 22, 2017

• FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response
• Tasigna (nilotinib) FDA Approval History

Tasigna (nilotinib)

Patient Population Altered: March 22, 2018

• Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia
• Tasigna (nilotinib) FDA Approval History