New Drug Approvals Archive - August 2005

Fortical (calcitonin) Nasal Spray

Date of Approval: August 12, 2005
Company: Unigene / Upsher-Smith Laboratories, Inc.
Treatment for: Osteoporosis

Fortical is a nasal calcitonin formulation indicated for the treatment of postmenopausal osteoporosis.

• Fortical Unigene / Upsher-Smith Laboratories, Inc. - Treatment for Postmenopausal Osteoporosis

Fortical (calcitonin) FDA Approval History

Actonel with Calcium (risedronate sodium and calcium carbonate)

Date of Approval: August 12, 2005
Company: Procter & Gamble Pharmaceuticals, Inc.
Treatment for: Osteoporosis

Actonel with Calcium (risedronate sodium and calcium carbonate) is a conveniently packaged combination of Actonel tablets (a bisphosphonate) and calcium tablets. Actonel with Calcium is a prescription therapy indicated for the prevention and treatment of postmenopausal osteoporosis.

• Actonel with Calcium Procter & Gamble Pharmaceuticals, Inc. - Treatment for Postmenopausal Osteoporosis

Actonel with Calcium (risedronate sodium and calcium carbonate) FDA Approval History

Nevanac (nepafenac) Ophthalmic Suspension

Date of Approval: August 19, 2005
Company: Alcon, Inc.
Treatment for: Postoperative Ocular Inflammation

Nevanac (nepafenac) is a topical nonsteroidal anti-inflammatory (NSAID) and analgesic prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.

• Nevanac Alcon, Inc. - Treatment for Pain and Inflammation Associated with Cataract Surgery

Nevanac (nepafenac) FDA Approval History

ACTOplus met (pioglitazone and metformin) Tablets

Date of Approval: August 29, 2005
Company: Takeda Pharmaceuticals
Treatment for: Diabetes Type 2

Actoplus met (pioglitazone and metformin) is a combination antihyperglycemic medication used in the management of type 2 diabetes.

• ACTOplus met Takeda Pharmaceuticals - Treatment for Type 2 Diabetes

ACTOplus met (pioglitazone and metformin) FDA Approval History

Increlex (mecasermin) Injection

Date of Approval: August 30, 2005
Company: Tercica, Inc.
Treatment for: Primary IGF-1 Deficiency

Increlex (mecasermin) contains human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. Increlex is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.

• Increlex Tercica, Inc. - Treatment for Short Stature Caused by Primary IGF-1 Deficiency

Increlex (mecasermin) FDA Approval History

Fluarix (influenza virus vaccine, inactivated)

Date of Approval: August 31, 2005
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis

Fluarix (influenza virus vaccine, inactivated) is an influenza virus vaccine indicated for adults and children (3 years and older) for the prevention of influenza disease.

• Fluarix GlaxoSmithKline - Treatment for Influenza Vaccination

Fluarix (influenza virus vaccine, inactivated) FDA Approval History

ACTOplus met (pioglitazone and metformin)

New Dosage Form Approved: May 12, 2009

• FDA Approves ACTOplus met XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes

ACTOplus met (pioglitazone and metformin) FDA Approval History

Fluarix (influenza virus vaccine, inactivated)

Patient Population Altered: October 19, 2009

• FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

Fluarix (influenza virus vaccine, inactivated) FDA Approval History

Fluarix (influenza virus vaccine, inactivated)

New Formulation Approved: December 17, 2012

• FDA Approves GlaxoSmithKline's Fluarix Quadrivalent - Four-strain Seasonal Influenza Vaccine for Use in the U.S.

Fluarix (influenza virus vaccine, inactivated) FDA Approval History