FDA Approvals - Formulary

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FDA Approvals
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First-time generic drug approvals, October 2009

October 1, 2009
By:Formulary journal staff

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

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

October 1, 2009
By:Formulary journal staff

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

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
By:Formulary journal staff

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

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

October 1, 2009
By:Formulary journal staff

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

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

October 1, 2009
By:Formulary journal staff

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

Sumatriptan (Sumavel DosePro): Needle-free injection of 5-HT1 receptor agonist approved for the acute treatment of migraine and cluster headaches

September 1, 2009
By:Formulary journal staff

New formulation: Sumatriptan (Sumavel DosePro) formulated as a needle-free injection was approved on July 15, 2009, for the acute treatment of migraine and cluster headaches

FDA actions in brief, September 2009 (Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, Kogenate FS)

September 1, 2009
By:Formulary journal staff

Recent FDA approvals (through September 2009) related to Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, and Kogenate FS

First-time generic drug approval, September 2009: Tacrolimus capsules

September 1, 2009
By:Formulary journal staff

Generic drug approved by FDA (through September 2009): tacrolimus capsules

Bevacizumab (Avastin): Monoclonal antibody approved for the treatment of metastatic renal cell carcinoma in combination with interferon alfa

September 1, 2009
By:Formulary journal staff

New indication: Bevacizumab (Avastin), a monoclonal antibody, was approved on July 31, 2009, for the treatment of metastatic renal cell carcinoma in combination with interferon alfa

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