New Drug Approvals Archive
Sanctura (trospium chloride)
New Dosage Form Approved: August 3, 2007
Selzentry (maraviroc) Tablets
Date of Approval: August 6, 2007
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).
New Formulation Approved: August 14, 2007
Zingo (lidocaine hydrochloride monohydrate) Dermal PowderJect
Date of Approval: August 16, 2007
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.
Reclast (zoledronic acid)
New Indication Approved: August 17, 2007
Patient Population Altered: August 22, 2007
Evithrom (human thrombin)
Date of Approval: August 27, 2007
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.
Somatuline Depot (lanreotide acetate) Injection - formerly Somatuline Autogel
Date of Approval: August 30, 2007
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.
ACAM2000 (Smallpox (Vaccinia) Vaccine, Live)
Date of Approval: August 31, 2007
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.
Zingo (lidocaine hydrochloride monohydrate)
Patient Population Altered: January 8, 2009