New Drug Approvals Archive - August 2007

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: ViiV Healthcare
Treatment for: HIV Infection

Selzentry (maraviroc) is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older.

• 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 Productto Reduce Pain Associated with Needle Insertion Procedures inChildren

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: Ipsen Biopharmaceuticals, Inc.
Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors

Somatuline Depot (lanreotide) is a long acting somatostatin analogue indicated for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors.

• 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

Somatuline Depot (lanreotide acetate)

New Indication Approved: December 16, 2014
Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors

• FDA Approves Somatuline Depot (lanreotide) for Gastroenteropancreatic Neuroendocrine Tumors

Somatuline Depot (lanreotide acetate) FDA Approval History

Selzentry (maraviroc)

New Formulation Approved: November 4, 2016

• ViiV Healthcare Announces FDA Approval of Selzentry (maraviroc) for Use in Children and Adolescents Living With HIV

Selzentry (maraviroc) FDA Approval History