Generic Products

Introvale Marketed by:

Sandoz (Princeton, NJ)

Compared to:

Seasonale (Duramed Pharmaceuticals)

Indication:

Sandoz announced the FDA approval and launch of Introvale (levonorgestrel and ethinyl estradiol tablets, USP), the generic equivalent of Duramed’s Seasonale. Introvale is an extended-cycle oral contraceptive consisting of 84 active tablets—each containing 0.15 mg of levonorgestrel, a synthetic progestogen, and 0.03 mg of ethinyl estradiol—and 7 placebo tablets. It is indicated for the prevention of pregnancy in women who choose oral contraceptives for birth control. Patients should be counseled that Introvale does not protect against HIV-infection (AIDS) or other sexually transmitted diseases, and that smoking while taking oral contraceptives increases the risk of cardiovascular side effects.

Dosage Form:

Tablets: 84 days of 0.15-mg levonorgestrel and 0.03 mg of ethinyl estradiol, followed by 7 days of inert tablets

For More Information:

www.us.sandoz.com; 609-627-8500 PT

Phentermine Hydrochloride Tablets Manufactured by:

Elite Pharmaceuticals Inc (Northvale, NJ)

Marketed by:

TAGI Pharma (a subsidiary of Precision Dose)

Compared to:

Adipex-P (Gate Pharmaceuticals)

Indication:

Elite Pharmaceuticals announced the FDA approval of phentermine (HCI), 37.5- mg tablets, a generic equivalent to Gate’s Adipex-P. Phentermine HCI is an anorexigenic indicated as a short-term adjunct to a weight loss regimen that includes exercise, behavoral modification, and caloric restriction for patients whose body mass index is at least 30, or 27 in the presence of additional risk factors. Patients taking phentermine HCl typically develop tolerance to its appetite-suppressing effect within a few weeks, after which the drug should be discontinued.

Dosage form:

Tablets: 37.5 mg

For More Information:

www.elitepharma.com; 201-802-4000

Opium Tincture, (Deodorized) Marketed by:

Paddock Laboratories (Minneapolis, MN)

Indication:

The FDA approved Paddock’s opium tincture (deodorized), a Schedule II drug indicated for the treatment of diarrhea. This preparation of morphine has been made suitable for oral administration through a process of “denarcotization” with a petroleum distillate, removing any unpleasant odor or nauseating substances. It is not recommended for children, and should not be used to treat diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract. Paddock’s opium tincture is supplied in 4-oz bottles containing 1 g of anhydrous morphine per 100 mL. The recommended adult dose is 0.6 mL taken orally 4 times a day.

Dosage Form:

Tincture: 10 mg of anhydrous morphine/ mL

For More Information:

www.paddocklabs.com; 800-328- 5113

Indomethacin Extended- Release Capsules Marketed by:

Amneal Pharmaceuticals (Glasgow, KY)

Indication:

Amneal announced the FDA approval and launch of indomethacin extended-release capsules, a nonsteroidal anti-inflammatory drug (NSAID) used to treat a variety of arthritic conditions. Amneal’s product is the AB-rated, therapeutically equivalent alternative to Merck’s Indocin SR. It is indicated for the treatment of pain, swelling, and stiffness caused by moderate to severe rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis, as well as acute shoulder pain caused by acute bursitis and/or tendonitis. Indomethacin capsules are supplied in 30-, 60-, 90-, and 500-count bottles. Patients taking NSAIDs may be at risk for ulcers and bleeding and should be urged to report serious gastrointestinal side effects to a health care provider.

Dosage form:

Capsules: 75 mg

For More Information:

www.amneal.com; 866-525-7270