New Medicines

Havidol (avafynetyme HCl) is a new faux-drug recently approved for treatment for dysphoric social attention consumption deficit anxiety disorder (DSACDAD). This disorder is now recognized to affect a large segment of our population. Havidol reduces symptoms of the disorder, making life stresses more tolerable.

The manufacturer, Future Pharms, notes that the drug is not a cure - it is palliative only. Havidol works by binding to receptors of the hormone hedonine, thereby improving the patient's sense of well-being.

Anyone seen this? or used these yet? I have, I suffer from chronic back pain from 5 back operations.

Tekturna (aliskiren), the first new class of hypertension drug in more than ten years, received FDA approval on March 6th. Tekturna is made by Novartis and will be available by prescription later this month.

Once daily administration of Tekturna blocks renin, a compound produced by the kidneys, which contributes to narrowing of blood vessels. Blocking renin relaxes the vessels and reduces blood pressure.

Tekturna has mild side effects but, like many other drugs, is contraindicated during pregnancy since Tekturna could harm an unborn baby.

For more information, please see the Tekturna website.

Pill Identification - TEKTURNA

150 mg - round light pink tablet imprinted NVR on one side and IL on the other side

300 mg - oval light red tablet imprinted NVR on one side and IU on the other side

First-Time Generic Approvals - February 2007

Tablets/Capsules Only

Pharmer.org Pill Identifier

• Citalopram Imprints
• Sertraline Imprints

Citalopram Note: Our citalopram table lists tablets only; Alphapharm's citalopram is the first generic to be marketed in the United States in capsule form.

Sertraline Note: Pfizer received a new drug application (NDA 19-839) for 150 mg and 200 mg sertraline (Zoloft) in December 1991. Pfizer never marketed these dosage forms, and the FDA left open the possibility that generic sertraline 150 mg and 200 mg could later be approved by the agency. Please see Federal Register: September 17, 2004 (Volume 69, Number 180) [Notices]

On February 23, 2007 the US Food and Drug Administration approved Vyvanse (lisdexamfetamine dimesylate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Vyvanse is a prodrug of dextroamphetamine that remains inactive until metabolized in the body. Vyvanse then converts to d-amphetamine and gradually releases the drug for convenient once-daily dosing.

According to the distributor, Shire US, since Vyvanse remains inactive until swallowed, its abuse potential is less than other stimulant drugs that treat ADHD.

Vyvanse will be available in the second quarter of 2007. For more information please visit the Shire ADHD Treatments website.

Pill Identification - VYVANSE

30 mg - white and orange capsules imprinted NRP 104 30 mg

50 mg - white and blue capsules imprinted NRP 104 50 mg

70 mg - blue and orange capsules imprinted NRP 104 70 mg

Last month the US Food and Drug Administration approved Alli (orlistat 60 mg capsules) for weight loss in adults.

Alli is the first FDA-approved diet medication to be available without a prescription. According to the manufacturer, GlaxoSmithKline, "...Alli helps people lose 50 percent more weight than diet alone." Combined with a low-fat, reduced-calorie diet, Alli prevents approximately 25% fat absorption.

Alli will be available over the counter in the summer of 2007. For more information, please visit the Alli website.

Orlistat in 120 mg dosage form will continue to be available by prescription only under the brand name Xenical made by Roche.

Whats Up! Just wondering Has anyone been prescribed Fentora, I take 800 mcg 2 x a day for BT pain. The med is to be placed between the gum and upper cheek at the rear molar and left there to disolve, I have had some pain and irritation at the application site, has anyone had this problem or know of any other different application instruction/method? This medication work very well for me better than any other BT med I have used, I do not want my Doc to stop the med because of this problem, it is not that bad.

Here is some information I ran across today while checking out a chronic pain board.  This information is courtesy of Ortho-McNeil's website, and will include a link at the end.

ALZA Corporation Receives FDA Approval for
IONSYSTM (fentanyl iontophoretic transdermal system)

The First Needle-Free, Patient-activated Analgesic System for Acute Postoperative Pain

Mountain View, CA, May 23, 2006- The US Food and Drug Administration (FDA) has approved IONSYSTM (fentanyl iontophoretic transdermal system), the first needle-free, patient-activated analgesic system. IONSYS is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization.

IONSYS is the first and only product to incorporate the proprietary E-TRANS® iontophoretic transdermal drug delivery system developed by ALZA. E-TRANS utilizes iontophoresis - a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body. IONSYS securely adheres to the upper outer arm or chest, and provides patients an on-demand dose of fentanyl. Fentanyl is an opioid analgesic that has been used in the management of pain for more than 40 years. Read more via this link

Last week the US Food and Drug Administration approved Amrix (cyclobenzaprine extended release) manufactured by ECR Pharmaceuticals.

Amrix is a skeletal muscle relaxant taken once daily for relief of acute muscle spasms. The medication is to be taken no longer than two or three weeks and should be combined with rest and physical therapy.

Current formulations of cyclobenzaprine necessitate taking the medication two or three times daily; Amrix is the first cyclobenzaprine formulation for once-daily administration.

Pill Identification - AMRIX

15 mg - orange capsules (with one white band) imprinted ECR 15

30 mg - blue and orange capsules (with two white bands) imprinted ECR 30

Please see our Common Imprints Identifier for additional cyclobenzaprine markings.

First-Time Generic Approvals - January 2007

Tablets/Capsules Only