FDA Approvals - Formulary

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

FDA Approvals

FDA actions in brief, November 2009 (FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena)

November 1, 2009

Recent FDA approvals (through November 2009) related to FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena

Valsartan and aliskiren (Valturna): Combination of an angiotensin receptor blocker with direct renin inhibitor approved for the treatment of hypertension

November 1, 2009

New combination: Valturna was approved on September 16, 2009, for the treatment of hypertension in patients not adequately controlled on either aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Ustekinumab (Stelara): First-in-class human monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasis

November 1, 2009

New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Telavancin for injection (Vibativ): Lipoglycopeptide antibiotic approved for the treatment of complicated skin and skin-structure infections

October 1, 2009

New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)

First-time generic drug approvals, October 2009

October 1, 2009

Generic drugs approved by FDA (through October 2009): 1% clindamycin/5% benzoyl peroxide gel, triamcinolone acetonide nasal spray, clonidine transdermal system, betamethasone acetate and betamathasone sodium phosphate injectable suspension

FDA actions in brief, October 2009 (Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, Bepreve)

October 1, 2009

Recent FDA approvals (through October 2009) related to Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, and Bepreve

Guanfacine extended-release tablets (Intuniv): Selective alpha2a-adrenergic receptor agonist approved for the treatment of ADHD

October 1, 2009

New formulation: Guanfacine extended-release tablets (Intuniv) were approved on September 2, 2009, for the treatment of attention-deficit/hyperactivity disorder (ADHD)

Morphine/naltrexone extended-release capsules (Embeda): Combination of mu-opioid agonist and mu-opioid antagonist approved for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period

October 1, 2009

New combination: Morphine/naltrexone extended-release capsules (Embeda) were approved on August 13, 2009, for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period

Saxagliptin (Onglyza): DPP-4 inhibitor approved for the treatment of type 2 diabetes mellitus

September 1, 2009

New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus

ADVERTISEMENT



Stay connected to Formulary
Receive web-exclusive articles, clinical news, and conference updates!

ADVERTISEMENT

Modern Medicine logoFormulary archives are now available on ModernMedicine.com, a new online resource designed to meet the evolving needs of physicians.
Register now (it's free and quick) or Find out more.

Keep visiting FormularyJournal.com for fresh content, news, opinions, editor's blogs and more.

ADVERTISEMENT

Click here