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New Drug Approvals Archive - August 2007

August 2007

Sanctura (trospium chloride)

New Dosage Form Approved: August 3, 2007

Read more: 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.

Read more: Selzentry (maraviroc) FDA Approval History

Ranexa (ranolazine)

New Formulation Approved: August 14, 2007

Read more: 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.

Read more: Zingo (lidocaine hydrochloride monohydrate) FDA Approval History

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.

Read more: 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; Carcinoid Syndrome

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

Read more: 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.

Read more: ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) FDA Approval History

Somatuline Depot (lanreotide acetate)

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

Read more: Somatuline Depot (lanreotide acetate) FDA Approval History

Somatuline Depot (lanreotide acetate)

New Indication Approved: September 15, 2017
Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome

Read more: Somatuline Depot (lanreotide acetate) FDA Approval History

New Drug Approvals Archive