Actavis’ generic Norvasc gets approval from FDA
NEW YORK The Food and Drug Administration approved Actavis Group’s generic version of a well-known high blood pressure medication, the company announced Friday.
The company said they were given the go-ahead to develop amlodipine besylate tablets, the generic form of Pfizer’s Norvasc. The medication will be available in 2.5, 5 and 10 mg doses.
Actavis, one of the leading generic pharmaceutical companies in the world, operates in close to 40 countries, and continues to expand its business with various product developments. The company became privately owned last month.
In the interim, shares of Pfizer fell 7 cents to $24.55 in morning trading.
Court denies Novartis injunction against Teva
JERUSALEM, Israel Teva Pharmaceutical Industries announced Wednesday that the U.S. District Court for the District of New Jersey denied a motion filed by Novartis for a preliminary injunction related to Teva’s famciclovir tablets, the generic version of Novartis’ Famvir.
The Food and Drug Administration already has approved Teva’s abbreviated new drug application for famciclovir tablets. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Famvir had U.S. annual sales of approximately $200 million for the twelve months ended June 30, according to IMS sales data.
Prescription drug abuse up among young adults
WASHINGTON More young adults are abusing prescription medications, according to the 2006 National Survey on Drug Use and Health from the U.S. Department of Health and Human Services. According to the results, 7 million Americans over 12 years old used prescription psychotherapeutic drugs—including pain relievers, tranquilizers, stimulants or sedatives—nonmedically in the month preceding the survey.
Overall prescription drug abuse among U.S. young adults increased from 5.4 percent in 2005 to 6.4 percent in 2006. Of the nonmedical prescription drug users in 2006, 5.2 million used prescription pain relievers, an increase from 4.7 million in 2005.
“The abuse of prescription drugs for nonmedical reasons is of increasing concern,” agency chief Terry Cline stated. “These are potent drugs that can have serious and life-threatening consequences if misused. Parents in particular need to be aware of this problem and take steps to prevent these medications from falling into the wrong hands.”
In 2006, 2.6 million people over 12 years old used psychotherapeutic drugs nonmedically for the first time, with the most significant increase being among the use of stimulants. The primary source of the drugs (55.7 percent) were friends and relatives who gave them away for free. About 19 percent were obtained from a doctor, and only 0.1 percent were purchased over the Internet.