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New Drug Approvals Archive - April 2016

See also: New Indications and Dosage Forms for 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.

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.

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.

Venclexta (venetoclax) Tablets

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

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated:

  • for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

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).

Cabometyx (cabozantinib) Tablets

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

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC), and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

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.

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.

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.

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.

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