New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

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: 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).

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: 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.

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

Hide
(web3)