New Drug Approvals Archive - September 2003

Seasonale (ethinyl estradiol and levonorgestrel) Tablets

Date of Approval: September 5, 2003
Company: Barr Laboratories
Treatment for: Contraception

Seasonale (ethinyl estradiol and levonorgestrel) is an extended-cycle oral contraceptive.

• Seasonale Barr Laboratories - Treatment for Prevention of Pregnancy

Riomet (metformin hydrochloride) Oral Solution

Date of Approval: September 11, 2003
Company: Ranbaxy Pharmaceuticals Inc.
Treatment for: Diabetes Type 2

Riomet is an oral solution formulation of the antihyperglycemic drug metformin indicated for the treatment of type 2 diabetes.

• Riomet Ranbaxy Pharmaceuticals Inc. - Treatment for Type 2 Diabetes

Cubicin (daptomycin ) Injection

Date of Approval: September 12, 2003
Company: Cubist Pharmaceuticals
Treatment for: Skin and Structure Infection, Bacteremia

Cubicin (daptomycin) is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia).

• Cubicin Cubist Pharmaceuticals - Treatment for Skin Infections

Cubicin (daptomycin )

New Dosage Regimen: November 30, 2010

• Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of Cubicin

Zomig Nasal Spray (zolmitriptan)

Patient Population Altered: June 12, 2015

• FDA Approves Zomig (zolmitriptan) Nasal Spray for Migraine in Pediatric Patients (Ages 12-17)