New Drug Approvals Archive

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July 2013

July 1

Latuda (lurasidone)

New Indication Approved: June 28, 2013

Latuda (lurasidone) FDA Approval History

July 2

Isentress (raltegravir)

Labeling Revision Approved: June 28, 2013

Isentress (raltegravir) FDA Approval History

July 3

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.

Zubsolv (buprenorphine and naloxone) FDA Approval History

July 10

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.

Khedezla (desvenlafaxine) FDA Approval History

July 12

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).

Gilotrif (afatinib) FDA Approval History

July 19

Simponi (golimumab)

New Dosage Form Approved: July 18, 2013

Simponi (golimumab) FDA Approval History

July 19

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.

Astagraf XL (tacrolimus) FDA Approval History

July 24

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.

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) FDA Approval History

July 25

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.

Injectafer (ferric carboxymaltose) FDA Approval History

July 25

Fetzima (levomilnacipran) Extended-Release Capsules

Date of Approval: July 25, 2013
Company: Forest Laboratories, Inc. and Pierre Fabre Laboratories
Treatment for: Depression

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

Fetzima (levomilnacipran) FDA Approval History

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