New Drug Approvals Archive - June 2011

June 2011

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.

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.

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.

Rectiv (nitroglycerin) Ointment

Date of Approval: June 21, 2011
Company: Allergan, Inc.
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.

LaViv (azficel-T)

Date of Approval: June 21, 2011
Company: Fibrocell Science, Inc.
Treatment for: Wrinkles

Azficel-T is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

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.

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.

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.