New Drug Approvals Archive - March 2012

FluMist (Influenza Virus Vaccine, Live, Intranasal)

New Formulation Approved: March 1, 2012

• FDA Approves FluMist Quadrivalent Vaccine to Prevent Seasonal Influenza

Ultresa (pancrelipase) Delayed Release Capsules

Date of Approval: March 1, 2012
Company: Allergan, 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.

• Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules

Ultresa (pancrelipase) FDA Approval History

Viokace (pancrelipase) Tablets

Date of Approval: March 1, 2012
Company: Allergan, 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.

• Aptalis Pharma Announces FDA Approval of Viokace (Pancrelipase) Tablets

Viokace (pancrelipase) FDA Approval History

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.

• Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome

Surfaxin (lucinactant) FDA Approval History

Natazia (dienogest and estradiol valerate)

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

• U.S. FDA Approves First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)

Natazia (dienogest and estradiol valerate) FDA Approval History

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.

• FDA Approves Binosto, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution

Binosto (alendronate) FDA Approval History

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).

• Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis

QNASL (beclomethasone dipropionate) FDA Approval History

Intelence (etravirine)

Patient Population Altered: March 26, 2012

• FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review

Intelence (etravirine) FDA Approval History

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.

• Affymax and Takeda Announce FDA Approval of Omontys (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis

Omontys (peginesatide) FDA Approval History

QNASL (beclomethasone dipropionate)

New Formulation Approved: December 17, 2014

• Teva Announces FDA Approval of QNASL for Children with Seasonal and Perennial Allergic Rhinitis

QNASL (beclomethasone dipropionate) FDA Approval History