New Drug Approvals Archive - April 2016

Descovy (emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: April 4, 2016
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Descovy (emtricitabine and tenofovir alafenamide) is a nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection.

• FDA Approves Descovy (emtricitabine and tenofovir alafenamide), Gilead’s Third TAF-Based HIV Therapy
• Descovy (emtricitabine and tenofovir alafenamide) FDA Approval History

Inflectra (infliximab-dyyb) Injection

Date of Approval: April 5, 2016
Company: Celltrion, Inc.
Treatment for: Crohn's Disease -- Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Inflectra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

• FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade
• Inflectra (infliximab-dyyb) FDA Approval History

BromSite (bromfenac) Ophthalmic Solution

Date of Approval: April 8, 2016
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Postoperative Ocular Inflammation

BromSite (bromfenac) is a low dose nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution for the treatment of inflammation and prevention of pain in patients undergoing cataract surgery.

• Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)
• BromSite (bromfenac) FDA Approval History

Venclexta (venetoclax) Tablets

Date of Approval: April 11, 2016
Company: AbbVie Inc.
Treatment for: Chronic Lymphocytic Leukemia

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion.

• FDA Approves Venclexta (venetoclax) for Chronic Lymphocytic Leukemia with 17p Deletion
• Venclexta (venetoclax) FDA Approval History

Gilotrif (afatinib)

New Indication Approved: April 15, 2016

• FDA Approves Gilotrif (afatinib) for Patients with Squamous Cell Carcinoma of the Lung
• Gilotrif (afatinib) FDA Approval History

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) Inhalation Aerosol

Date of Approval: April 25, 2016
Company: AstraZeneca Pharmaceuticals LP
Treatment for: Chronic Obstructive Pulmonary Disease

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) is a long -acting beta₂-adrenergic agonist (LABA) and anticholinergic combination indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

• Bevespi Aerosphere Approved by the FDA for Patients with COPD
• Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) FDA Approval History

Cabometyx (cabozantinib) Tablets

Date of Approval: April 25, 2016
Company: Exelixis, Inc.
Treatment for: Renal Cell Carcinoma

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

• Exelixis Announces FDA Approval of Cabometyx (cabozantinib) for Patients with Advanced Renal Cell Carcinoma
• Cabometyx (cabozantinib) FDA Approval History

Xtampza ER (oxycodone) Extended-Release Capsules

Date of Approval: April 26, 2016
Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain

Xtampza ER (oxycodone) is an extended-release, abuse-deterrent, narcotic analgesic for the treatment of chronic pain.

• Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties
• Xtampza ER (oxycodone) FDA Approval History

Nuplazid (pimavanserin) Tablets and Capsules

Date of Approval: April 29, 2016
Company: Acadia Pharmaceuticals Inc.
Treatment for: Parkinson’s Disease Psychosis

Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.

• FDA Approves Nuplazid (pimavanserin) for Parkinson’s Disease Psychosis
• Nuplazid (pimavanserin) FDA Approval History

Gadavist (gadobutrol)

New Indication Approved: April 27, 2016

• FDA Approves Bayer's Gadavist (gadobutrol) Injection for use with Magnetic Resonance Angiography of Supra-Aortic Arteries
• Gadavist (gadobutrol) FDA Approval History

ProAir RespiClick (albuterol sulfate)

Patient Population Altered: April 29, 2016

• Teva Announces FDA Approval of ProAir RespiClick (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11
• ProAir RespiClick (albuterol sulfate) FDA Approval History

Akovaz (ephedrine sulfate) Injection

Date of Approval: April 29, 2016
Company: Flamel Technologies
Treatment for: Hypotension

Akovaz (ephedrine sulfate) is a pressor agent administered parenterally to address clinically important hypotension in surgical settings.

• Flamel Technologies Receives FDA Approval of Akovaz (ephedrine sulfate) for Surgical Hypotension
• Akovaz (ephedrine sulfate) FDA Approval History

Otovel (ciprofloxacin and fluocinolone acetonide) Otic Solution

Date of Approval: April 29, 2016
Company: Laboratorios Salvat S.A. and Arbor Pharmaceuticals, LLC
Treatment for: Acute Otitis Media with Tympanostomy Tubes

Otovel otic solution (ciprofloxacin and fluocinolone acetonide) is a fluoroquinolone antibacterial and corticosteroid combination indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients.

• Laboratorios Salvat S.A. and Arbor Pharmaceuticals, LLC Announce the Launch of Otovel (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) Otic Solution
• Otovel (ciprofloxacin and fluocinolone acetonide) FDA Approval History

Cabometyx (cabozantinib)

New Indication Approved: December 19, 2017

• Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Untreated Advanced Renal Cell Carcinoma
• Cabometyx (cabozantinib) FDA Approval History

Venclexta (venetoclax)

New Indication Approved: June 8, 2018

• Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia
• Venclexta (venetoclax) FDA Approval History

Nuplazid (pimavanserin)

New Dosage Form Approved: June 29, 2018
Treatment for: Parkinson’s Disease Psychosis

• Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)
• Nuplazid (pimavanserin) FDA Approval History