MPR New Drug Products

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New Drug Products

KORLYM

5/14/2012

Corcept Therapeutics

Pharmacological Class: Cortisol receptor blocker.

Active Ingredient(s): Mifepristone 300mg; tabs.

Indication: To control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and have failed surgery or are not candidates for surgery.

VORAXAZE

5/7/2012

BTG International

Pharmacological Class: Carboxypeptidase enzyme.

Active Ingredient(s): Glucarpidase; 1,000 Units/vial; lyophilized powder for IV injection after reconstitution; preservative-free.

Indication: Treatment of toxic plasma methotrexate (MTX) concentrations (>1 micromole per liter) in patients with delayed MTX clearance due to impaired renal function.

QNASL

4/30/2012

Teva Pharmaceuticals

Pharmacological Class: Steroid.

Active Ingredient(s): Beclomethasone dipropionate 80mcg/actuation; non-aqueous nasal spray soln.

Indication: Seasonal and perennial allergic rhinitis.

EXPAREL

4/23/2012

Pacira Pharmaceuticals

Pharmacological Class: Local anesthetic (amide-type).

Active Ingredient(s): Bupivacaine 13.3mg/mL; liposome injectable suspension; preservative-free.

Indication: For administration into the surgical site to produce postsurgical analgesia.

ARCAPTA NEOHALER

4/16/2012

Novartis Pharmaceuticals Corp

Pharmacological Class: Long-acting beta₂-agonist (LABA).

Active Ingredient(s): Indacaterol 75mcg; inhalation pwd hard capsules for use with Neohaler device.

Indication: Long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and/or emphysema.

ZIOPTAN

4/9/2012

Merck & Co., Inc.

Pharmacological Class: Prostaglandin analog

Active Ingredient(s): Tafluprost 0.0015%; oph soln; preservative-free.

Indication: For reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

INTERMEZZO

4/2/2012

Purdue Pharma L.P.

Pharmacological Class: Imidazopyridine hypnotic.

Active Ingredient(s): Zolpidem tartrate 1.75mg, 3.5mg; sublingual tablets.

Indication: As needed use for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Not indicated for treatment of middle-of-the-night insomnia when the patient has <4 hours of bedtime remaining before the planned time of waking.

INLYTA

3/26/2012

Pfizer Inc.

Pharmacological Class: Kinase inhibitor.

Active Ingredient(s): Axitinib 1mg, 5mg; tabs.

Indication: Treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

ERIVEDGE

3/19/2012

Genentech, Inc.

Pharmacological Class: Hedgehog pathway inhibitor.

Active Ingredient(s): Vismodegib 150mg; caps.

Indication: Treatment of adults with metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.