Magazine article Drug Topics

New Product Newswire

Magazine article Drug Topics

New Product Newswire

Article excerpt

RX

NEW DRUGS

Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has received tentative approval for a new treatment option for patients with high blood pressure, although not for initial therapy. Exforge (valsartan and amlodipine besylate) will provide combinahon therapy in a single tablet made up of Novartis' Diovan and Pfizer's Norvasc.

Coria Laboratories, Fort Worth, (866) 819-9007, has a new prescription-nonsteroidal shampoo for the treatment of scalp psoriasis and other hyperkeratotic scalp disorders. According to the company, Salex (6% w/w salicylic acid) shampoo is up to three times stronger than over-the-counter salicylic acid scalp preparations, delivering sufficient levels of active agent to remove the thick plaques and scales of scalp psoriasis. It is non-irritating to the eyes and can be used with colored or permed hair. It should not be used in children under two years of age.

BioSante Pharmaceuticals, Lincolnshire, Ill., (847) 478-0500, has received marketing approval for BioE-Gel (estradiol gel) in the United States. The product, approved in strengths of 0.87 gm per day and 1.7 gm per day, will carry the name Elestrin and will be marketed by Bradley Pharmaceuticals, Fairfield, N.J., (973) 882-1505, through its Kenwood Therapeutics Division. Elestrin, a topically applied gel, is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

NEW FORMULATIONS

A new formulation of Ability (aripiprazole) is now available from Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000. Ability Injection is an injectable form of the drug for intramuscular use. It is indicated for rapid control of agitation in adults with schizophrenia or bipolar mania at primary endpoint of two hours. It is available in a single-dose vial of 9.75 mg/1.3 mL.

REINTRODUCTION

From Warner Chilcott Laboratories, Rockaway, N.J., (973) 442-3200, comes a chewable birth control pill. Taken once daily, Femcon Fe (norethindrone, and ethinyl estradiol) is available as a 28-day regimen in a blisterpack of 21 white tablets and even brown (inactive) tablets, each one containing 75 mg of ferrous sulfate (hence the Fe in the name of the drug). The pill may be chewed followed by a full glass of liquid, or it may be swallowed whole. The drug was formerly named Ovcon 35 Chewable, introduced in September 2006.

NEW INDICATION

FDA has granted to Merck & Co., Whitehouse Station, N.J., (908) 423-1000, a new indication for Invanz (ertapenem). The injectable antibiotic is now indicated to combat the surgical-site infections that can occur following elective colorectal surgery in adults. It is administered once daily.

NEW GENERICS

The FDA has approved the first generic versions of ondansetron tablets, orally disintegrating tablets, and oral solution. The drug is indicated for the prevention of nausea and vomiting associated with surgery, radiotherapy, and cancer chemotherapy. Manufacturers of this generic alternative to GlaxoSmithKline's Zofran are: Bedford Laboratories, (Bedford, Ohio, (440) 232-3320, ondansetron injection (2 mg/mL packaged in 4 mg/2 mL single-dose vials and 40 mg/20 mL multi-dose vials); Dr. Reddy's Laboratories, Bridgewater, N.J., (908) 203-4900, ondansetron hydrochloride tablets (4, 8, 16, and 24 mg); Hospira Inc., Lake Forest, Ill., (847) 937-6100, ondansetron injection, (4-mg single-dose vial and 40-mg multi-dose vial); Kali Laboratories, Somerset, N.J., (732) 537-0400, ondansetron orally disintegrating tablets (4, 8, 16, and 24 mg); Par Pharmaceutical, Woodcliff Lake, N.J., (800) 828-9393, ondansetron orally disintegrating tablets (4- and 8-mg); Barr Laboratories subsidiary Pliva Inc., East Hanover, N.J., (973) 386-5566, ondansetron orally disintegrating tablets (4- and 8-mg); and Roxane Laboratories, Columbus, Ohio, (614) 272-4774, ondansetron hydrochloride oral solution (4 mg [base]/5 mL).

Pliva Inc. has received approval for 10-, 20-, and 40-mg pravastatin tablets, along with tentative approval for 80 mg. …

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