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New Drug Approvals Archive - July 2013

See also: New Indications and Dosage Forms for July 2013

July 2013

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013
Company: Orexo AB
Treatment for: Opiate Dependence

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

Khedezla (desvenlafaxine) Extended-Release Tablets

Date of Approval: July 10, 2013
Company: Osmotica Pharmaceutical Corp.
Treatment for: Depression

Khedezla (desvenlafaxine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

Gilotrif (afatinib) Tablets

Date of Approval: July 12, 2013
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Non-Small Cell Lung Cancer

Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

Astagraf XL (tacrolimus) Extended-Release Capsules

Date of Approval: July 19, 2013
Company: Astellas Pharma US, Inc.
Treatment for: Organ Transplant -- Rejection Prophylaxis

Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant.

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) Tablets

Date of Approval: July 24, 2013
Company: Warner Chilcott plc
Treatment for: Contraception

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.

Injectafer (ferric carboxymaltose) Injection

Date of Approval: July 25, 2013
Company: Luitpold Pharmaceuticals, Inc.
Treatment for: Iron Deficiency Anemia

Injectafer (ferric carboxymaltose) is an iron replacement product indicated for the treatment of iron deficiency anemia.

Fetzima (levomilnacipran) Extended-Release Capsules

Date of Approval: July 25, 2013
Company: Allergan, Inc.
Treatment for: Depression

Fetzima (levomilnacipran) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013
Company: Orexo AB
Treatment for: Opiate Dependence

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

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