New Drug Approvals Archive

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June 2011

June 8

Humalog (insulin lispro)

Labeling Revision Approved: May 18, 2011

June 10

Potiga (ezogabine) Tablets

Date of Approval: June 10, 2011
Company: GlaxoSmithKline and Valeant Pharmaceuticals International
Treatment for: Seizures

Potiga (ezogabine) is a potassium channel opener indicated for the adjunctive treatment of adults with partial-onset seizures.

Potiga (ezogabine) FDA Approval History

June 14

Creon (pancrelipase)

New Dosage Form Approved: June 10, 2011

Creon (pancrelipase) FDA Approval History

June 15

Nulojix (belatacept) Injection

Date of Approval: June 15, 2011
Company: Bristol-Myers Squibb Company
Treatment for: Organ Transplant -- Rejection Prophylaxis

Nulojix (belatacept) is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Nulojix (belatacept) FDA Approval History

June 17

Istodax (romidepsin)

New Indication Approved: June 16, 2011

Istodax (romidepsin) FDA Approval History

June 17

Oxecta (oxycodone) Tablets - formerly Acurox

Date of Approval: June 17, 2011
Company: Pfizer Inc. and Acura Pharmaceuticals Inc.
Treatment for: Pain

Oxecta (oxycodone hydrochloride) is an abuse-deterrent opioid analgesic formulation for the relief of moderate to severe pain.

Oxecta (oxycodone) FDA Approval History

June 21

Lupron Depot (leuprolide acetate)

New Dosage Regimen: June 17, 2011

June 21

Rectiv (nitroglycerin) Ointment - formerly Cellegesic

Date of Approval: June 21, 2011
Company: ProStrakan Group plc
Treatment for: Anal Fissure and Fistula

Rectiv (nitroglycerin) is a topical ointment for the treatment of moderate to severe pain associated with chronic anal fissures.

Rectiv (nitroglycerin) FDA Approval History

June 22

laViv (azficel-T)

Date of Approval: June 22, 2011
Company: Fibrocell Science, Inc.
Treatment for: Wrinkles

Azficel-T is an autologous cell therapy for the treatment of moderate to severe nasolabial fold wrinkles in adults.

laViv (azficel-T) FDA Approval History

June 8

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive, an antihistamine, and a nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold and upper respiratory allergies.

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) FDA Approval History

June 8

Rezira (hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Rezira (hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive and nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold.

Rezira (hydrocodone and pseudoephedrine) FDA Approval History

June 30

Lazanda (fentanyl) Nasal Spray - formerly NasalFent

Date of Approval: June 30, 2011
Company: Archimedes Pharma
Treatment for: Pain

Lazanda (fentanyl) is an opioid analgesic nasal spray for the management of breakthrough pain in cancer patients.

Lazanda (fentanyl) FDA Approval History

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