New Drug Approvals Archive

Sanctura (trospium chloride)

New Dosage Form Approved: August 3, 2007

• Indevus Announces FDA Approval of Sanctura XR

Sanctura (trospium chloride) FDA Approval History

Selzentry (maraviroc) Tablets

Date of Approval: August 6, 2007
Company: Pfizer Inc.
Treatment for: HIV Infection

Selzentry (maraviroc) is the first in a class of drugs known as CCR5 antagonists, approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load).

• Pfizer's Selzentry (Maraviroc) Tablets, Novel Treatment for HIV, Approved by FDA

Selzentry (maraviroc) FDA Approval History

Ranexa (ranolazine)

New Formulation Approved: August 14, 2007

• CV Therapeutics Launches 1000 mg Ranexa Tablet

Ranexa (ranolazine) FDA Approval History

Zingo (lidocaine hydrochloride monohydrate) Dermal PowderJect

Date of Approval: August 16, 2007
Company: Anesiva, Inc.
Treatment for: Local Anesthesia

Zingo (lidocaine hydrochloride monohydrate) is a needle-free, local anesthetic intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws.

• Anesiva Receives FDA Approval for Zingo, a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children

Zingo (lidocaine hydrochloride monohydrate) FDA Approval History

Reclast (zoledronic acid)

New Indication Approved: August 17, 2007

• Reclast Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis

Reclast (zoledronic acid) FDA Approval History

Risperdal (risperidone)

Patient Population Altered: August 22, 2007

• FDA Approves Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania

Evithrom (human thrombin)

Date of Approval: August 27, 2007
Company: Omrix Biopharmaceuticals, Ltd,
Treatment for: Bleeding

Evithrom is a highly purified human thrombin used as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.

• FDA Approves Evithrom (human thrombin) for Topical Use in Surgery

Evithrom (human thrombin) FDA Approval History

Somatuline Depot (lanreotide acetate) Injection - formerly Somatuline Autogel

Date of Approval: August 30, 2007
Company: Tercica, Inc.
Treatment for: Acromegaly

Somatuline Depot is a sustained-release injection formulation of lanreotide, a somatostatin analogue indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

• Ipsen: Somatuline Depot Receives Marketing Approval in the United States for the Treatment of Acromegaly

Somatuline Depot (lanreotide acetate) FDA Approval History

ACAM2000 (Smallpox (Vaccinia) Vaccine, Live)

Date of Approval: August 31, 2007
Company: Acambis Inc.
Treatment for: Smallpox Prophylaxis

ACAM2000 is live vaccinia virus smallpox vaccine intended for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks.

• FDA Approves ACAM2000 Vaccine for Protection Against Smallpox

ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) FDA Approval History

Zingo (lidocaine hydrochloride monohydrate)

Patient Population Altered: January 8, 2009

• Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults

Zingo (lidocaine hydrochloride monohydrate) FDA Approval History