Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

th

Year

Volume: 05

Number: 45

18th February 2012

Content Letrozole banned for induction of ovulation in anovulatory infertility in India FDA approves Testosterone Gel for hypogonadism FDA approved 35 innovative new drugs in fiscal year 2011 Implantable pump for Morphine receives premarket approval from FDA WHO issues clarification for use of Progestin-Only injectable contraceptives Forthcoming Event

Letrozole banned for induction of ovulation in anovulatory infertility in India

FDA approves Testosterone Gel for hypogonadism Bloomberg News reports, "Teva Pharmaceutical Industries Ltd...and BioSante Pharmaceuticals Inc...won" the US Food and Drug Administration "clearance to sell Bio-T-Gel [testosterone], a testosterone replacement therapy for men." In an email, the agency said it "approved the transdermal gel" to treat a "condition, known as hypogonadism," which "can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota. Teva, of Petach Tikva, Israel, will market Bio-T-Gel." FDA approved 35 innovative new drugs in fiscal year 2011 Report shows quick approvals of safe and effective medicines occur in the United States before other countries. Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkins lymphoma in 30 years; and the first new drug for lupus in 50 years. In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained.

The report shows faster approval times in the United States when compared to the FDAs counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines. Thirty-five major drug approvals in one year represent a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients, said Margaret Hamburg, M.D., Commissioner of Food and Drugs. We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century. Among the new drugs approved in FY 2011, a number are notable for their advances in patient care and for the efficiency with which they were approved: Two of the drugs one for melanoma and one for lung cancer are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits; Seven of the new medicines provide major advances in cancer treatment; Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection; Ten are for rare or orphan diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;

3 Almost half (16) were approved under priority review, in which the FDA has a six month goal to complete its review for safety and effectiveness; Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information; Three were approved using accelerated approval, a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program; and Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months. The Prescription Drug User Fee Act was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012. Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere, said Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research. As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy. In October 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies. Implantable pump receives premarket FDA for Morphine approval from

Med Page Today reported, "The FDA has given premarket approval to an implantable, programmable pump (Prometra) for intraspinal administration of preservative-free morphine sulfate sterile solution (Infumorph)." The device "is the first non-peristaltic, programmable, implantable" pump to "receive FDA approval for delivery of Infumorph, according to a statement from Medasys, the device maker." The agency's "approval was granted after the pump met PMA safety and efficacy requirements, and also showed a 97% accuracy in healthcare professional-programmed dose delivery during clinical trials, the statement added." WHO issues clarification for use of Progestin-Only injectable contraceptives The World Health Organization (WHO) announced that it is adding a clarification to the medical eligibility criteria for the use of progestin-only injectable contraceptives. The clarification states that while this method is recommended for use without restriction, women at high risk of HIV who choose progestin-only injectable contraceptives to meet their family planning intentions should be strongly advised to also use condoms and other HIV-preventive measures. This announcement follows an expert meeting convened by WHO during which participants reviewed existing evidence on whether the use of progestin-only

4 injectable contraception influences a woman's likelihood of contracting HIV. "The bottom line is that the current evidence is limited and inconclusive," said Dr. Charles Morrison, Senior Director of Clinical Sciences at FHI 360 and a participant of the WHO review. "This issue remains an important, unanswered public health question. We must make it a priority to find more conclusive evidence." "The WHO clarification is a starting point," commented Dr. Ward Cates, Distinguished Scientist and President Emeritus at FHI 360, who chaired a session at the WHO meeting. "In addition to providing women with better evidence on the safety of available contraceptives, we need to expand the method mix so they have more options, including highly effective longacting contraception and multipurpose methods to prevent both sexuallytransmitted infections and unintended pregnancies." <http://www.who.int/mediacentre/news/n otes/2012/contraceptives_20120216/en/in dex.html>WHO News Release <http://www.who.int/reproductivehealth/t opics/family_planning/Hormonal_contracep tion_and_HIV.pdf>WHO Technical Statement (PDF, 174 KB)] <http://www.fhi360.org/NR/rdonlyres/ey4 emmiyxzmxbw3opnpbdkdy3rkajc6k2mdu6f rtssaep2l4sh7x3mvyrkbpe3drfzjtsdgxe4iprl/ HCHIVQA021613.pdf>Question & Answer (PDF, 206 KB) About FHI 360: In 2011, FHI acquired AED's projects and teams of experts to form a new entity - FHI 360. FHI 360 is a leading human development organization dedicated to improving lives in lasting ways by advancing integrated, locally-driven solutions. Professional staff includes experts in education, health, nutrition, economic development, civil society and environment - as well as cross-cutting experts in gender issues, youth, research, applied science, behavior change and technology - creating a unique mix of capabilities to address today's diverse and inter-related development challenges. FHI 360 operates in countries around the world, including the United States. CONTACT: Hannah Burris 703.647.1951 <mailto:hburris@fhi360.org>hburris@fhi36 0.org Forthcoming Event:

IPA Convention-2012
17-18th March 2012 Theme: Excellence in Pharma Education Venue: Manipal College of Pharmaceutical Sciences Manipal University, Manipal For details contact: http://www.ipapharma.org/ Organizing Secretary: Dr. N. Udupa Scientific Programme Committee Chairman: Dr. Surendra Manek