Pharmaceutical company Lupin has received tentative approval from the United States Food and Drug Administration to market its cholesterol lowering Pitavastatin tablets in the American market. has received approval for Pitavastatin tablets in the strength of 1 milligram, 2 mg and 4 mg. Pitavastatin is a generic version of Kowa's Livalo tablets in t
Aurobindo Pharma has received US Food and Drug Administration's approval for two of its generic drugs, following which the company stocks gained positive traction. Aurobindo Pharma has received US Food and Drug Administration's approval for two of its generic drugs, following which the company stocks gained positive traction. Aurobindo Pharma Ltd i
-Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the Company is scheduled to present at the annual Biotech ShowcaseTM conference on January 11, 2017.
CANONSBURG- Mylan is posting a strong gain in afternoon trading on Friday, with shares of the drug maker climbing by 2.5 percent. The gain by Mylan comes after the company announced the launch of a generic version on Johnson& Johnson's Concerta tablets for the treatment of Attention Deficit Hyperactivity Disorder. Mylan also announced the launch of
This week, Lupin received tentative approval for generic Giazo Tablets, Aurobindo Pharma got US FDA approval for 2 drugs and Glenmark Pharma gets USFDA approval for Tretinoin Capsules. Lupin receives tentative approval for generic Giazo Tablets Pharma Major Lupin Limited announced that it has received tentative approval for its Balasalazide Disodiu
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the table have informed FDA that these drug products are no longer
SUMMARY: The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product." This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009.
Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the Company is scheduled to present at the annual Biotech Showcase TM conference on January 11, 2017.
Lupin's Balasalazide Disodium tablets 1.1 gm are the AB rated generic equivalent of Salix Pharmaceuticals Inc's Giazo Tablets, 1.1 gm.Pharma Major Lupin Limited announced today that it has received tentative approval for its Balasalazide Disodium Tablets, 1.1 gm from the United States Food and Drug Administration to market a generic version of Sali
HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2016/ PRNewswire/ Mylan N.V., today announced the U.S. launch of Fosphenytoin Sodium Injection USP, 75 mg/mL,, packaged in 100 mg PE*/ 2 mL, and 500 mg PE*/ 10 mL single-use vials, a generic version of Pfizer's Cerebyx Injection. Fosphenytoin Sodium Injection USP, 75 mg/mL,, packaged in 100 mg PE
HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2016/ PRNewswire/ Mylan N.V., today announced the U.S. launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a generic version of Janssen's Concerta Tablets. This launch also further strengthens our robust portfolio of central nervous system medicati
SHANGHAI: When her father's lung cancer worsened, Yin Min, a 51- year-old financial broker from Shanghai, faced a choice: pay nearly $3,000 a month for an approved drug or pay a fraction of the price for a generic drug not approved for use in China. Yin, like many families in China, turned to the increasingly popular, unregulated market of online p
-Concordia International Corp., an international specialty pharmaceutical company focused on generic and legacy pharmaceutical products and orphan drugs, today announced that effective January 1, 2017, John Beighton will retire from his current role as President of the Company's International segment. Mr. Duncan joined Amdipharm Mercury Limited in.
Over 60 percent of Americans want the government to take action to lower prescription drug prices, according to a new Kaiser Family Foundation survey. Congress, for once, is listening to voters. To protect consumers, the FDA requires that new drugs undergo a series of clinical trials to prove their safety and effectiveness before entering the marke
Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for selling its generic version of tretinoin capsules 10 mg. The drug is used for the treatment of leukaemia. Tretinoin capsules are the generic version of Vesanoid Capsules 10 mg of Hoffmann La Roche Inc. The drug is no longer marketed in USA..
HERTFORDSHIRE, England and PITTSBURGH, Dec. 28, 2016/ PRNewswire/ Mylan N.V., today announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg/ 0.05 mg. Mylan's subsidiary, Jai Pharma Limited, received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product
A woman talks on a mobile phone as she walks past the closed research facility of Semler Research Centre in Bengaluru, India, October 13, 2016. HYDERABAD: Vasudeva Prakash left his job as a mechanic in Hyderabad three years ago for what he calls a more lucrative career: taking part in clinical trials on generic drugs. Prakash provided documentation
Most recently, Rich was Executive Vice President and Chief Financial officer of Unilife Corporation, a NASDAQ- traded medical device company. His first CFO position was with LyphoMed Inc., a generic pharmaceutical company with revenues of~ $225 million that was eventually acquired by Fujisawa Pharmaceutical Co. Ltd. Rich began his career at Procter
According to a recently published report, the Biosimilars Market is expected to grow at the CAGR of 22.6% during 2015-2022. The segmentation of global biosimilars market is based on product type, application, technology, services and geography. The report on Global Biosimilars Market Forecast, 2015-2022 provides detailed overview and predictive ana
According to data from OECD, the average American spent nearly $1,100 a year on pharmaceuticals, nearly $400 more than second-place Canada. That high cost is one reason the U.S. spends almost $2,300 more per person in health care costs. However, a study by the University of Cincinnati found that there is a significant placebo effect attached to pay
Glenmark Pharmaceuticals rose 0.49% to Rs 893.50 at 9:53 IST on BSE after the company said it received abbreviated new drug application approval for Tretinoin capsules. Glenmark Pharmaceuticals Inc., USA received final approval from the United States Food& Drug Administration for Tretinoin capsules, 10 milligrams, the generic version of Vesanoid...
The high prices Americans might for generic drugs may have been cooked up pharmaceutical salespeople on golf courses, at a New Jersey steakhouse or over drinks at "Girls Nights Out" in Minnesota. "The wining and the dining and the dinners and the social repertoire sort of led to an atmosphere in which follow-up conversations could occur where pric
Plus, there is pricing pressure on the US generics side, "said Dhiraj Sachdev, senior fund manager at HSBC Global Asset Management. Among mid-cap pharmaceutical companies, Wockhardt is the biggest laggard as it has lost 60% of its value this year due to delay in resolution of the US FDA related issues. Recently, Divi`s Laboratories fell under the F
By a News Reporter-Staff News Editor at Cancer Weekly New research on Oncology- Cancer Research is the subject of a report. For more information on this research see: Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study. Clinical Cancer Research, 2016; 22: 5167-5170. Clinical Cancer Research can be contacted
ANI Pharmaceuticals, Inc. today announced that it has acquired Inderal XL from Cranford Pharmaceuticals, LLC and InnoPran XL from Holmdel Pharmaceuticals LP. Inderal XL and InnoPran XL generated combined sales of $23.3 million in calendar year 2016, according to IMS Health. Arthur S. Przybyl, ANI's President and CEO stated, "We are ex