New Drug Approvals Archive

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August 2005

August 12

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 (calcitonin) FDA Approval History

August 12

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 (risedronate sodium and calcium carbonate) FDA Approval History

August 19

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 (nepafenac) FDA Approval History

August 29

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 (pioglitazone and metformin) FDA Approval History

August 30

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 (mecasermin) FDA Approval History

August 31

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 (influenza virus vaccine, inactivated) FDA Approval History

May 13

ACTOplus met (pioglitazone and metformin)

New Dosage Form Approved: May 12, 2009

ACTOplus met (pioglitazone and metformin) FDA Approval History

October 19

Fluarix (influenza virus vaccine, inactivated)

Patient Population Altered: October 19, 2009

Fluarix (influenza virus vaccine, inactivated) FDA Approval History

December 17

Fluarix (influenza virus vaccine, inactivated)

New Formulation Approved: December 17, 2012

Fluarix (influenza virus vaccine, inactivated) FDA Approval History

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