New Drug Approvals Archive

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March 2012

March 1

FluMist (Influenza Virus Vaccine, Live, Intranasal)

New Formulation Approved: March 1, 2012

March 1

Ultresa (pancrelipase) Delayed Release Capsules

Date of Approval: March 1, 2012
Company: Aptalis Pharma U.S. Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Ultresa (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Ultresa (pancrelipase) FDA Approval History

March 1

Viokace (pancrelipase) Tablets

Date of Approval: March 1, 2012
Company: Aptalis Pharma U.S. Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Viokace (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases. Viokace, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.

Viokace (pancrelipase) FDA Approval History

March 6

Surfaxin (lucinactant) Intratracheal Suspension

Date of Approval: March 6, 2012
Company: Discovery Laboratories, Inc.
Treatment for: Respiratory Distress Syndrome

Surfaxin (lucinactant) is a synthetic, peptide-containing surfactant indicated for the prevention of respiratory distress syndrome (RDS) in premature infants.

Surfaxin (lucinactant) FDA Approval History

March 15

Natazia (dienogest and estradiol valerate)

New Indication Approved: March 14, 2012
Treatment for: Contraception, Heavy Menstrual Bleeding

Natazia (dienogest and estradiol valerate) FDA Approval History

March 12

Binosto (alendronate) Effervescent Tablets - formerly EX101

Date of Approval: March 12, 2012
Company: EffRx Pharmaceuticals SA
Treatment for: Osteoporosis

Binosto (alendronate) is a buffered effervescent dosage form of the bisphosphonate drug alendronate sodium administered once weekly for the treatment of osteoporosis.

Binosto (alendronate) FDA Approval History

March 23

QNASL (beclomethasone dipropionate) Nasal Aerosol - formerly BDP Nasal HFA

Date of Approval: March 23, 2012
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Allergic Rhinitis

QNASL (beclomethasone dipropionate) is an intranasal corticosteroid non-aqueous "dry" spray formulation for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).

QNASL (beclomethasone dipropionate) FDA Approval History

March 27

Intelence (etravirine)

Patient Population Altered: March 26, 2012

Intelence (etravirine) FDA Approval History

March 27

Omontys (peginesatide) Injection - formerly Hematide

Date of Approval: March 27, 2012
Company: Affymax, Inc. and Takeda Pharmaceutical Company Limited
Treatment for: Anemia Associated with Chronic Renal Failure

Omontys (peginesatide) an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Omontys (peginesatide) FDA Approval History

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