New Drug Approvals Archive - October 2015

Opdivo (nivolumab)

New Dosage Regimen: September 30, 2015

• BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma

Opdivo (nivolumab) FDA Approval History

Juvederm (dermal filler)

New Formulation Approved: October 1, 2015
Treatment for: Facial Rejuvenation

• FDA Approves Juvéderm Ultra XC for Lip Augmentation

Juvederm (dermal filler) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: October 2, 2015

• FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer

Keytruda (pembrolizumab) FDA Approval History

Letairis (ambrisentan)

Labeling Revision Approved: October 2, 2015

• FDA Approves New Treatment Combination of Gilead’s Letairis with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1)

Letairis (ambrisentan) FDA Approval History

MorphaBond (morphine sulfate) Extended-Release Tablets

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

MorphaBond (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.

• FDA Approves MorphaBond (morphine sulfate) Extended-Release Tablets with Abuse-Deterrent Properties

MorphaBond (morphine sulfate) FDA Approval History

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.

• FDA Approves Aristada (aripiprazole lauroxil) for Schizophrenia

Aristada (aripiprazole lauroxil) FDA Approval History

Opdivo (nivolumab)

Labeling Revision Approved: October 9, 2015

• FDA Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer

Opdivo (nivolumab) FDA Approval History

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).

• FDA Approves Praxbind (idarucizumab) as a Reversal Agent for the Anticoagulant Pradaxa

Praxbind (idarucizumab) FDA Approval History

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.

• LEO Pharma Announces U.S. Approval of Enstilar Foam (calcipotriene/betamethasone dipropionate) for Plaque Psoriasis

Enstilar (betamethasone dipropionate and calcipotriene) FDA Approval History

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).

• Tris Pharma Receives FDA Approval of Dyanavel XR (amphetamine) Once-Daily Liquid for ADHD in Children

Dyanavel XR (amphetamine) FDA Approval History

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.

• FDA Approves Coagadex (coagulation factor X (human)) for Hereditary Factor X Deficiency

Coagadex (coagulation factor X (human)) FDA Approval History

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.

• FDA Approves Veltassa (patiromer) for Hyperkalemia

Veltassa (patiromer) FDA Approval History

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.

• FDA Approves Onivyde (irinotecan liposome injection) for Advanced Pancreatic Cancer

Onivyde (irinotecan liposomal) FDA Approval History

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.

• FDA Approves Yondelis (trabectedin) for the Treatment of Specific Soft Tissue Sarcomas

Yondelis (trabectedin) FDA Approval History

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).

• FDA Approves Strensiq (asfotase alfa) for Perinatal, Infantile and Juvenile-Onset Hypophosphatasia

Strensiq (asfotase alfa) FDA Approval History

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.

• FDA Approves Vivlodex (meloxicam) for Osteoarthritis Pain

Vivlodex (meloxicam) FDA Approval History

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.

• FDA Approves Belbuca (buprenorphine) Buccal Film for Chronic Pain Management

Belbuca (buprenorphine hydrochloride) FDA Approval History

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.

• FDA Approves Imlygic (talimogene laherparepvec) for the Treatment of Melanoma

Imlygic (talimogene laherparepvec) FDA Approval History

Yervoy (ipilimumab)

New Indication Approved: October 28, 2015

• FDA Approves Yervoy to Reduce the Risk of Melanoma Returning after Surgery

Yervoy (ipilimumab) FDA Approval History

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).

• FDA Approves Utibron Neohaler (indacaterol/glycopyrrolate) for COPD

Utibron Neohaler (glycopyrrolate and indacaterol) FDA Approval History

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).

• FDA Approves Seebri Neohaler (glycopyrrolate) for COPD

Seebri Neohaler (glycopyrrolate) FDA Approval History

Veltassa (patiromer)

Labeling Revision Approved: November 25, 2016

• FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions

Veltassa (patiromer) FDA Approval History

Aristada (aripiprazole lauroxil)

New Dosage Regimen: June 5, 2017

• FDA Approves Two-Month Aristada for Treatment of Schizophrenia

Aristada (aripiprazole lauroxil) FDA Approval History