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Atrix Laboratories, Fort Collins, Colo., (970) 482-5868, has received FDA approval for Eligard 7.5 mg (formerly Leuprogel One-Month Depot), leuprolide acetate for subcutaneous injection, for the treatment of advanced prostate cancer. Sanofi-Synthelabo Inc. will be Atrix' marketing partner for the Eligard product line; Atrix will manufacture the product. Eligard is in liquid form when injected subcutaneously with a small-gauge needle; once in the body, it forms a solid implant that slowly releases the leuprolide acetate over a period of one month.
Solaraze (diclofenac sodium) Gel from Bioglan Pharma Inc., Malvern, Pa., (610) 232-2000, is now available for treatment of actinic keratosis. Solaraze Gel is the first FDA-approved drug containing the NSAID diclofenac sodium in a 3% topical formulation. The product is a nongreasy gel, which is applied twice daily for two to three months.
Rare Disease Therapeutics Inc., Nashville, (615) 399-0700, has received FDA approval to market Orfadin Capsules (nitisinone), an orphan-designated product, as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type I. If left untreated, the acute form of this extremely rare disease can be fatal in the first year of life.
Chiron Corp., Emeryville, Calif., (510) 655-8730, and Berlex Laboratories Inc., the U.S. affiliate of Schering AG, have received FDA approval for a new room-temperature formulation of Betaseron (interferon beta-1b) for SC Injection. The new formulation of Betaseron, which is indicated for treatment of relapsing-remitting multiple sclerosis, is the first MS therapy available as a room temperature (25°C/77°F) formulation. Betaseron was jointly developed by Chiron and Berlex. In the U.S. and Canada, it is manufactured by Chiron and sold by Berlex. The new formulation will come out in midyear.
Prevacid (lansoprazole) for Delayed-Release Oral Suspension from TAP Pharmaceutical Products, Lake Forest, Ill., (800) 621-1020, is now available by prescription nationwide. The new formulation is designed to accommodate the special needs of pa-tients who have difficulty swallowing capsules. The Delayed-Release Oral Suspension is equivalent to the Prevacid capsule formulation, which is used in the treatment of acid-related disorders, such as GERD. The new formulation, which was approved by the FDA in May 2001, will be available in packets with strengths of 15 mg and 30 mg. It eliminates the need to swallow or open a capsule for alternative administration options. Patients can simply empty the strawberry-flavored contents into a container with 2 tbs. of water, stir well, and drink immediately. If any of the contents remains after drinking, patients should add more water, stir, and drink immediately. Patients should not mix the oral suspension with other liquids or foods and should not crush or chew the granules.
Akorn Inc., Buffalo Grove, Ill., (800) 932-5676, has received FDA approval to launch Paremyd (hydroxyamphetamine hydrobromide 1% and tropicide 0.25%), a topical mydriatic/ cycloplegic combination product that Akorn acquired from Allergan Inc. in 1997. Paremyd is indicated for pupil dilation in routine ophthalmic diagnostic procedures and eye exams. The product will be manufactured in Akorn's Somerset, N.J., facility. Paremyd is scheduled for launch in March 2002.
Barr Laboratories Inc., Pomona, N.Y., (800) BARR LAB, has received FDA approval of its application to manufacture and market a generic version of GlaxoSmithKline's Dexedrine Spansule Capsules sustained-release 5 mg, 10 mg, and 15 mg. Barr's AB-rated generic dextroamphetamine sulfate, 5 mg, 10 mg, and 15 mg, is indicated for the treatment of narcolepsy and for attention deficit disorder with hyperactivity, as an integral part of a total treatment program. The product should be available this month.
A new AB-rated generic alternative to Fioricet with Codeine (Novartis) is now available from Amarin Pharmaceuticals, Warren, N.J., (908) 580-5535. New phrenilin with caffeine and codeine (butalbital, acetaminophen, caffeine, and codeine phosphate capsules, 50mg/ 325mg/40mg/30mg) was approved by the FDA in August of last year. The product is indicated for treatment of tension headache.
Mylan Laboratories Inc., Pittsburgh, (412) 232-0100, has received FDA approval for its metformin HCl tablets, 500 mg, 850 mg, and 1,000 mg. Mylan's metformin HCl is the generic version of Bristol-Myers Squibb's Glucophage tablets, which are indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes.
The FDA has granted Purepac Pharmaceutical Co., Elizabeth, N.J., (908) 527-9100, a subsidiary of Alpharma, Fort Lee, N.J., tentative approval to manufacture and market lisinopril 2.5-mg, 5-mg, and 10-mg tablets. Alpharma's lisinopril tablets, which will be marketed under the Purepac brand, are the generic equivalent of AstraZeneca's branded product Zestril, which is indicated for the treatment of hypertension, as adjunctive therapy for the treatment of heart failure, and to improve survival after myocardial infarction. The final approval of Alpharma's generic version of lisinopril is pending the expiration of a patent related to the product.
TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, has been granted "approvable" status by the FDA for its tramadol HCl tablets, 50 mg. This product is the AB-rated generic version of RW Johnson's Ultram, indicated for the management of moderate to moderately severe pain. TEVA has also been awarded tentative FDA approval for mirtazapine tablets, 15 mg, 30 mg, and 45 mg, an AB-rated generic version of the branded product Remeron (Organon). The tentative approval is for the use of mirtazapine as monotherapy for the treatment of depression.
The Zilactin line of nonprescription products from Zila Pharmaceuticals Inc., Phoenix, (602) 266-6700, are now sore-specific for various mouth sores and have new packaging that clearly positions each product for specific indications. Zilactin Cold Sore Gel creates a bandage-like film that lasts up to six hours, promoting healing and relieving pain. Zilactin Cold Sore Liquid treats cold sores and fever blisters even before they break out. The liquid formulation contains lidocaine for pain relief.
Zilactin Canker Sore Gel treats painful lesions inside the mouth with benzocaine. The bandage-like film protects the sore and holds the medication in place for up to six hours. Two other Zilactin products, Zilactin Toothache and Oral Pain Swabs and Zilactin Baby Teething Gel, also have new packaging.
New ultra-thin, disposable heat wraps that deliver consistent, low-level heat for at least eight hours are now available from Procter & Gamble, Cincinnati, (800) 347-1565. ThermaCare Air-Activated Heat Wraps are designed to provide pain relief plus deep muscle relaxation to the user. Heat discs in ThermaCare contain a mixture of common materials that, when exposed to air, give off a low-level heat that reaches a therapeutic temperature (104°F) within 30 minutes. The wraps are available in three customized ver-sions: one for the back, one for neck-to-arm multi-use, and one for the lower abdomen (for menstrual pain).
Maddak Inc., Pequannock, N.J., (973) 628-7600, is introducing the Ableware Handy Cup, a two-handled transparent cup with an extra-wide base, which provides a secure grip and stability while reducing the occurrence of accidental spills. Its angled design affords space for the nose and eyeglasses while making it possible to drink with little or no neck movement.
Nancy Jillard. New Product Newswire. Drug Topics 2002;4:77.
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