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

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)

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

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

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

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

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

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%

Isentress (raltegravir)

Labeling Revision Approved: January 29, 2009

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

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

Isentress (raltegravir)

Patient Population Altered: December 21, 2011

FDA Expands Use of HIV Drug Isentress to Children and Adolescents

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)

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)

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

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)

Patient Population Altered: March 22, 2018

Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia