Skip to Content

New Drug Approvals Archive - August 2007

August 2007

August 6

Sanctura (trospium chloride)

New Dosage Form Approved: August 3, 2007

Sanctura (trospium chloride) FDA Approval History

August 6

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.

Selzentry (maraviroc) FDA Approval History

August 14

Ranexa (ranolazine)

New Formulation Approved: August 14, 2007

Ranexa (ranolazine) FDA Approval History

August 16

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.

Zingo (lidocaine hydrochloride monohydrate) FDA Approval History

August 20

Reclast (zoledronic acid)

New Indication Approved: August 17, 2007

Reclast (zoledronic acid) FDA Approval History

August 22

Risperdal (risperidone)

Patient Population Altered: August 22, 2007

August 27

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.

Evithrom (human thrombin) FDA Approval History

August 30

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.

Somatuline Depot (lanreotide acetate) FDA Approval History

August 31

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.

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

January 9

Zingo (lidocaine hydrochloride monohydrate)

Patient Population Altered: January 8, 2009

Zingo (lidocaine hydrochloride monohydrate) FDA Approval History

December 16

Somatuline Depot (lanreotide acetate)

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

Somatuline Depot (lanreotide acetate) FDA Approval History

November 4

Selzentry (maraviroc)

New Formulation Approved: November 4, 2016

Selzentry (maraviroc) FDA Approval History

New Drug Approvals Archive