New Drug Approvals Archive

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October 2007

October 1

Symlin (pramlintide acetate)

New Dosage Form Approved: September 25, 2007

Symlin (pramlintide acetate) FDA Approval History

October 1

Taxotere (docetaxel)

New Indication Approved: September 28, 2007

October 12

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.

Isentress (raltegravir) FDA Approval History

October 15

Velcade (bortezomib)

Patient Population Altered: October 10, 2007

October 12

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.

Doribax (doripenem) FDA Approval History

October 16

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.

Ixempra (ixabepilone) FDA Approval History

October 17

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 (diclofenac sodium) FDA Approval History

October 19

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.

Renvela (sevelamer carbonate) FDA Approval History

October 29

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 (nilotinib) FDA Approval History

October 30

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.

Combigan (brimonidine tartrate and timolol maleate) FDA Approval History

February 5

Isentress (raltegravir)

Labeling Revision Approved: January 29, 2009

Isentress (raltegravir) FDA Approval History

June 18

Tasigna (nilotinib)

New Indication Approved: June 17, 2010

Tasigna (nilotinib) FDA Approval History

December 21

Isentress (raltegravir)

Patient Population Altered: December 21, 2011

Isentress (raltegravir) FDA Approval History

July 2

Isentress (raltegravir)

Labeling Revision Approved: June 28, 2013

Isentress (raltegravir) FDA Approval History

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