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New Drug Approvals Archive - April 2016

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.

Read more: 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.

Read more: 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.

Read more: 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.

Read more: Venclexta (venetoclax) 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).

Read more: 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).

Read more: 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.

Read more: Xtampza ER (oxycodone) FDA Approval History

Nuplazid (pimavanserin) Tablets

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.

Read more: Nuplazid (pimavanserin) 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.

Read more: 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.

Read more: Otovel (ciprofloxacin and fluocinolone acetonide) FDA Approval History

New Drug Approvals Archive