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New Drug Approvals Archive - October 2015

See also: New Indications and Dosage Forms for October 2015

October 2015

MorphaBond ER (morphine sulfate) Extended-Release Tablets

Date of Approval: October 2, 2015
Company: Inspirion Delivery Technologies, LLC
Treatment for: Pain

MorphaBond ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Aristada (aripiprazole lauroxil) Injection

Date of Approval: October 5, 2015
Company: Alkermes plc
Treatment for: Schizophrenia

Aristada (aripiprazole lauroxil) is an extended-release injectable atypical antipsychotic with one-month, six-week, and two-month dosing options for the treatment of schizophrenia.

Praxbind (idarucizumab) Injection

Date of Approval: October 16, 2015
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Reversal Agent for Pradaxa

Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa).

Enstilar (betamethasone dipropionate and calcipotriene) Foam

Date of Approval: October 16, 2015
Company: LEO Pharma
Treatment for: Plaque Psoriasis

Enstilar (betamethasone dipropionate and calcipotriene) is a topical corticosteroid and vitamin D analogue foam formulation for the treatment of psoriasis vulgaris.

Dyanavel XR (amphetamine) Extended-Release Oral Suspension

Date of Approval: October 19, 2015
Company: Tris Pharma, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Dyanavel XR (amphetamine) is an extended-release central nervous system (CNS) stimulant in an oral suspension formulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Coagadex (coagulation factor X (human)) Injection

Date of Approval: October 20, 2015
Company: Bio Products Laboratory Limited
Treatment for: Hereditary Factor X Deficiency

Coagadex (coagulation factor X (human)) is a human factor X concentrate for the treatment of hereditary factor X deficiency.

Veltassa (patiromer) for Oral Suspension

Date of Approval: October 21, 2015
Company: Relypsa, Inc.
Treatment for: Hyperkalemia

Veltassa (patiromer) is an oral potassium binder for the treatment of hyperkalemia.

Onivyde (irinotecan liposomal) Injection - formerly MM-398

Date of Approval: October 22, 2015
Company: Merrimack Pharmaceuticals, Inc.
Treatment for: Pancreatic Cancer

Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan indicated for the treatment of post-gemcitabine metastatic adenocarcinoma of the pancreas.

Yondelis (trabectedin) for Injection

Date of Approval: October 23, 2015
Company: Janssen Biotech, Inc.
Treatment for: Soft Tissue Sarcoma

Yondelis (trabectedin) is a cytotoxic antitumor agent for the treatment of unresectable or metastatic liposarcoma or leiomyosarcoma, two common subtypes of soft tissue sarcoma.

Strensiq (asfotase alfa) Injection

Date of Approval: October 23, 2015
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Hypophosphatasia

Strensiq (asfotase alfa) is a tissue nonspecific alkaline phosphatase enzyme replacement therapy indicated for the treatment of patients with perinatal, infantile and juvenile-onset hypophosphatasia (HPP).

Vivlodex (meloxicam) Capsules

Date of Approval: October 22, 2015
Company: Iroko Pharmaceuticals, LLC
Treatment for: Osteoarthritis

Vivlodex (meloxicam) is a low dose nonsteroidal anti-inflammatory drug (NSAID) indicated for the management of osteoarthritis pain.

Belbuca (buprenorphine hydrochloride) Buccal Film

Date of Approval: October 23, 2015
Company: Endo Pharmaceuticals Inc.
Treatment for: Chronic Pain

Belbuca (buprenorphine) is a partial opioid agonist analgesic in a buccal film formulation for the management of chronic pain.

Imlygic (talimogene laherparepvec) Injection

Date of Approval: October 27, 2015
Company: Amgen Inc.
Treatment for: Melanoma

Imlygic (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of melanoma lesions in the skin and lymph nodes.

Utibron Neohaler (glycopyrrolate and indacaterol) Inhalation Powder

Date of Approval: October 29, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Chronic Obstructive Pulmonary Disease

Utibron Neohaler (glycopyrrolate and indacaterol) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) fixed-dose combination for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Seebri Neohaler (glycopyrrolate) Inhalation Powder

Date of Approval: October 29, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Chronic Obstructive Pulmonary Disease

Seebri Neohaler (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

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