FDA Approves Dexamethasone Elixir and Orsythia

The FDA has approved Qualitest Pharmaceuticals’ dexamethasone elixir 0.5 mg/5 mL and Orsythia tablets (levonorgestrel/ethinyl estradiol tablets 0.1 mg/0.02 mg). Dexamethasone is used to treat a variety of conditions including endocrine disorders, rheumatic disorders, and collagen disease. Orsythia is indicated for the prevention of pregnancy in women who choose oral contraceptives as a method of contraception.

DR. REDDY’S LABS LAUNCHES THREE GENERIC PRODUCTS IN USA

Dr Reddy's Laboratories announced on Jun. 6, 2011 that it launched three generic drugs in the US market. The drugs are used to treat central nervous system disorders and were all approved by the US drug regulator in the last two weeks.

Donepezil Hydrochloride tablets is a remake of Japan based Eisai Pharma's Aricept and its sale in the US alone fetched the company over $ 2 billion for the financial year 2011.

The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA for Donepezil HCl tablets on May 31, 2011. The drug is available in 5mg and 10mg strengths in 30, 90 and 500 count bottles.

The second drug released- Venlafaxine Hydrochloride Extended Release capsules- is a copy cat of Wyeth's Effexor XR ® and is used to treat depression and social anxiety. Dr. Reddy’s will be competing with bigger generic players like Mylan and Teva who are their version of this drug in the US.

The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA for Venlafaxine Hydrochloride Extended Release Capsules on May 05, 2011.

Effexor accounted for $ 2.3 billion of Wyeth's total sales. All three strengths of Dr. Reddy’s Venlafaxine Hydrochloride Extended Release Capsules are available in 30, 90 and 500 count bottles.

Letrozole tablets, available in 2.5 mg potency, are a cheaper (bioequivalent generic) version of Novartis' Femara ® and are used to treat menopausal disorders.

The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA for Letrozole tablets, USP on June 3, 2011. According to IMS Health, the pharmaceutical intelligence firm, Femara clocked in sales of $ 720 million in US in the last financial year. Dr. Reddy’s Letrozole tablets, USP are available in 30 count bottles.

GS K INCREASES PRODUCTION EFFICIENCY WITH CUSTOM FILLING SYSTEM

Single-use dosing system eliminates risk of cross-contamination and speeds production start-up time. GlaxoSmithKline (GSK) is a global research-based pharmaceutical and healthcare company committed to improving the quality of human life by enabling people to do more, feel better, and live longer.

GSK’s manufacturing plant in Barnard Castle, U.K. manufactures a range of medicines including sterile liquids in vials and syringes, as well as antibiotics and topical products like Zovirax. The site also plays a key role new product launches. To support a product introduction, GSK needed a new filling solution that could eliminate cross-contamination while ensuring operational efficiency. In addition to advanced line equipment, the company required a partner to provide expertise and support services throughout the life of the project as well as to help extend its line capacity for future products.

With a long-term relationship already established, GSK turned to Bosch Packaging Technology. The two companies have partnership for years, with proven success in the installation and service of several filling lines. GSK chose to work with Bosch for its technology, support, and maintenance services.

FDA GRANTS ORPHAN DRUG DESIGNATION TO EDISON PHARMA’S EPI-743

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Edison Pharmaceuticals’ EPI-743 as a treatment for inherited mitochondrial respiratory chain diseases.

EPI-743, an orally absorbed small molecule that readily crosses into the central nervous system, works by targeting an enzyme NADPH quinone oxidoreductase 1 (NQO1). EPI-743 is in phase 2B/3 pivotal clinical trials.

The FDA has given the orphan drug status on the basis of their review of the application which included clinical and pre-clinical data demonstrating a favorable efficacy and safety profile.

Edison Pharma is a patient- and physician-founded company devoted to developing new medicines for rare and neglected diseases. Currently, Edison Pharma (www.edisonpharma.com) is working on inherited mitochondrial diseases for which there are no approved drugs

JOHNSON & JOHNSON UNVEILS REVITALI ZED PIPELINE

Johnson & Johnson says it plan to seek approval for 11 new products and more than 30 important product line extensions between 2011 and 2015 as it emphasizes internal R&D investments, leverages strategic licensing, partnerships, and select acquisition deal to bolster its long-term outlook.

Open Info Day: IMI's 4th Call for Proposals

The Innovative Medicines Initiative (IMI) warmly encourages small and medium-sized enterprises, patient organisations, regulatory authorities, academic teams, industry, hospitals and other organisations with an interest in IMI projects to take part in the IMI Open Info Day.

Attendees will have the opportunity to directly interact with the coordinators of the topics of IMI's 4th Call for proposals, which will be launched soon. The Open Info Day will feature workshops on the different Call topics, as well as more general presentations on how to apply for IMI funding. There will be extensive networking opportunities with IMI staff and representatives of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

ASTRAZENECA PAYS $250K FOR SEX DISCRIMINATION

AstraZeneca will pay $250,000 to 124 women who were subjected to pay discrimination while working at an office in Wayne, Pennsylvania, according to the US Department of Labor, which filed a lawsuit last year alleging the drugmaker discriminated against female sales reps by paying them salaries that were, on average, $1,700 less than their male counterparts.

The department’s Office of Federal Contract Compliance Programs conducted a scheduled compliance review of the business center in 2002 and found that AstraZeneca had violated Executive Order 11246 by failing to meet its obligations as a federal contractor to ensure employees were paid fairly without regard to sex, race, color, religion and national origin.

IMPAX LABS GETS FDA WARNING ON MANUFACTURING

Generic drugmaker Impax Laboratories Inc. said on June 6 that it received a warning from the Food and Drug Administration (FDA) about manufacturing practices at its Hayward plant.

The warning letter reported that during a review, FDA inspectors found problems in the company's sampling and testing, its production record review, and the process it used to determine why manufacturing batches did not meet quality specifications.

PFIZER TO CUT ANOTHER $1 BILLION IN EXPENSES

Faced with growing generic competition and an insufficient pipeline, Pfizer execs are scrambling some more and plan to cut another $1 billion or so in expenses on top of the billions in cuts that have already been drained from R&D and marketing over the past few years, The Wall Street Journal reports.

The first phase of the cutbacks will amount to $500 million and take place later this year, with the rest coming next year. “We’re going to take out another billion dollars of our expenses,” Pfizer ceo Ian Read was quoted as saying, according to the paper.

A Pfizer spokesman adds that “we’re focused on operating in new, more effective and efficient ways, while at the same time continuing to invest where opportunities are robust.”

FDA: Some Prostate Drugs Actually Raise Cancer Risk

NEW YORK -- The Food and Drug Administration expanded the warning label on a group of prostate drugs Thursday, saying they may increase the risk of a more serious form of prostate cancer.

The FDA is updating the warning information on a group of drugs including GlaxoSmithKline PLC's Avodart and Merck & Co.'s Proscar, which are used to shrink the prostate. The warning indicates the drugs are linked to a greater risk of high-grade prostate cancers. While the drugs have been shown to reduce the risk of prostate cancer overall, the FDA said the drugs were linked to an increased risk of more serious cancers.

Earlier this year, Merck, based in Whitehouse Station, N.J., and British drugmaker GlaxoSmithKline asked the FDA to approve the drugs as preventive treatments for prostate cancer, but the agency refused, citing the risk of high-grade cancer. In March, GlaxoSmithKline said it was abandoning global efforts to get Avodart approved as a preventive cancer drug.

The agency is basing its conclusions on a review of two studies in which about 27,000 men 50 and older used the drugs for several years. The FDA said the risk of high-grade prostate cancers is small, but doctors should be aware of it.

MERCK, GSK DRUGS ADD WARNINGS ABOUT PROSTRATE CANCER RISK

Merck & Co. and GlaxoSmithKline Plc (GSK)’s drugs for hair loss and enlarged prostate will carry new U.S. warnings about a low risk of being diagnosed with a more serious form of prostate cancer.

The Food and Drug Administration revised the prescribing information for Merck’s Proscar and Propecia and Glaxo’s Avodart and Jalyn based on the findings of two studies, the agency said on Jun. 9, 2011 in a statement. From 2002 to 2009 about 5 million men were prescribed one of these drugs, known as 5-ARIs, including almost 3 million men ages 50 to 79, the FDA said.

LILLY WINS RULING IN DISPUTE WITH AMYLIN

Eli Lilly & Co. won a ruling in a lawsuit brought by Amylin Pharmaceuticals Inc., which wants to prevent Lilly from using the same people to sell Amylin’s diabetes drug and that of a competitor.

A federal judge in San Diego denied Amylin’s request for a preliminary order that would have imposed restrictions on Lilly’s diabetes sales force, the Indianapolis-based drugmaker said in a statement today. “We are pleased with the court’s decision,” Robert A. Armitage, Lilly’s general counsel, said in the statement. “We believe that Amylin’s allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation.”

Amylin, based in San Diego, sued Lilly last month, saying the manner in which Lilly plans to implement an agreement to develop and sell Boehringer Ingelheim GmbH’s type 2 diabetes drug breached its agreement to develop and commercialize Amylin’s competing drugs. Amylin said in a statement today it will pursue the litigation.

“Amylin continues to believe that Lilly’s conduct violates our diabetes collaboration agreements, is anti-competitive and limits patients’ treatment options,” the company said. “It is important to note that the court’s decision did not make any findings on the merits of our claims, but merely declines to award injunctive relief, based on the conclusion that monetary damages would be sufficient.”

The lawsuit is filed under seal and court documents weren’t immediately available.

GERMANY SUSPENDS TOP TAKEDA DIABETES DRUG ACTOS

Moves follow study showing slightly raised cancer risk.

Germany has joined France in suspending the use of Takeda Pharmaceutical's Actos diabetes drug, due to worries about a possible link to cancer.

The move is a blow for the Japanese firm, whose best-selling drug has worldwide sales of close to $5 billion, though the financial impact will be limited by the fact the drug faces looming generic competition in key markets. Shares in Takeda fell 2.9 percent on Jun. 10, 2011, against a 0.5 percent rise in the benchmark Nikkei average.

On Jun. 9, 2011, France's drug safety authority suspended use of both Actos and Competact -- which combines Actos and an older drug called metformin -- after an official French study found they appeared to slightly raise the risk of bladder cancer.

Germany's Federal Institute for Drugs and Medical Devices (BfArM) said it had decided to follow suit after receiving results of the study by France's national health insurance body, which tracked patients on diabetes drugs between 2006 and 2009.

“BfArM recommends the suspension of approval of pioglitazone (Actos) until further clarification. Doctors should not put new patients on pioglitazone,” the German regulator said in a statement.