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

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

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

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