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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

December 19

QNASL (beclomethasone dipropionate)

New Formulation Approved: December 17, 2014

QNASL (beclomethasone dipropionate) FDA Approval History

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