What is the significance of ANDA filing by a Pharmaceutical Company?
402294
Some drug formulations contain the same active compound as an earlier approved drug; these are the so-called generic drugs. Manufacturers of these types of drugs can request expedited FDA approval by filing an Abbreviated New Drug Application (ANDA). Under this filing, the evidence of safety and efficacy submitted to the FDA in connection with the previous "brand name" drug is used to help establish the safety and efficacy of the new drug. However, the FDC Act requires the ANDA to include a patent certification statement listing each patent that claims the drug or which claims a use for the drug. The ANDA applicant may rely on the information provided in the Orange Book for the certification statement. Specifically, the ANDA must include one of the following statements:\nSuch patent information has not been filed. \nSuch patent has expired. \nSuch patent will expire on a particular date. \nSuch patent is invalid or will not be infringed by the manufacture, use, or sale of the drug for which approval is being sought.
389555
I would go to the pharmacy company's website to find out. If need be, call the doctor's office and find out. It doesnt hurt to ask.
869278
Yes. Schedule 2 class drugs have to be accounted for. There is a book that the pharmacist must log info in that states the prescription, amount, date, and other important information. They are also locked up and only the pharmacist has access to them.
674277
is what companies like P&G do
352892
Thanks for asking! I am a business librarian, so I will consult the "Business and Company Resource Database" to give you the complete company history:\n\n1949: Jay Van Andel and Richard M. DeVos form a partnership to distribute vitamins for the Nutrilite Co. of California. \n\n1959 Sept.: Amway Sales Corp. and Amway Distributors Association are formed to help the company's distributors. With assistance from their wives, Van Andel is the creative mind behind company sales literature along with supervising product manufacturing, and DeVos sparks the interest of probable distributors. \n\n1959: Jay Van Andel and Richard DeVos found the American Way Association, later renamed the Amway Distributors Association. A biodegradable liquid organic cleaner serves as the company's first product. \n\n1960: Sales top $500,000. Amway introduces S-A-8, a new laundry detergent. \n\n1961: Amway sales top $1 million for the first time. \n\n1962: Sales double and hit the $2 million mark. The company expands into Canada. The first Ruby Direct Distributor award is given, recognizing distributor's sales milestones. \n\n1964: Sales reach $10 million. Amway merges three separate divisions and creates the Amway Corp. Van Andel serves as chairman, and DeVos acts as president. \n\n1965: The company sponsors magazine, newspaper, radio, and TV advertising. \n\n1966: Another sales milestone is reached and the first Double Diamond "DD" is awarded. \n\n1968: Amway distributes its Personal Shoppers Catalog, which contains other companies' products. The firm has 80,000 distributors selling over 150 different products. \n\n1969 July: Fire destroys the plant responsible for the manufacturing of Amway's aerosol products. \n\n1969: A Triple Diamond sales milestone is achieved. Amway finds itself under investigation by the Federal Trade Commission who claim the company is involved in an illegal pyramid scheme. \n\n1970: The first Crown DD, one level above the Triple Diamond, is given. \n\n1971: Amway builds a plant in Australia, its first plant overseas. \n\n1972: Amway buys Nutrilite Products, Inc., the company where Van Andel and De Vos first worked together. \n\n1973: The company begins new operations in the United Kingdom. \n\n1974: Amway introduces its products to the Asian market in Hong Kong. \n\n1975: West Germany serves as the sight for Amway's newest operation. The FTC files formal charges against Amway. \n\n1976: Asian operations continue to grow with the addition of a new Amway plant in Malaysia. \n\n1977 May: Hearings begin for the FTC charges. \n\n1977: European operations continue with the addition of a plant in France; the first Crown Ambassador DD is given for reaching the highest possible sales milestone; Amway buys the Mutual Broadcasting System. Van Andel and De Vos introduce their eight children to Amway and begin preparing them for take-over of the family business. \n\n1978: Amway opens operations in the Netherlands and the Republic of Ireland. The company buys a resort and hotel complex in the British Virgin Islands for the personal use of Amway distributors. \n\n1979: Amway opens a plant in Japan. The Federal Trade Commission decides Amway is not and never was involved in any type of illegal pyramid scheme. \n\n1980: Continuing international expansion, Amway builds new plants in Switzerland and Belgium. \n\n1982: Van Andel chairs the Netherlands-American Bicentennial Commission. \n\n1983: The company pleads guilty to the charge of not paying millions of dollars in customs duties goods imported from the United States to Canada and pays a $25 million Canadian fine in an out-of-court settlement. \n\n1984: Seven of Van Andel's and De Vos' children hold administrative positions. William W. Nicholson becomes a COO. Amway celebrates its 75th anniversary. \n\n1985: MCI asks Amway to market its long-distance telephone services. Due to lack of success, the company sells all of the Mutual Broadcasting
822229
All medications are chemicals. Many of them have more side effects than they have actions on the medical conditions they were prescribed to alleviate. Because of litigation, no drug manufacturer deliberately produces a dangerous medication. It simply happens because the FDA cannot test long enough.
429412
I think GAAP rules have changed now. Now gain is recognized when the substance is commercial. if its non commercial then no gain is recognized
418492
if u have heard this in ny state then it must be   Digital Record of Patients for Enhanced Analysis & Medication (DREAM) this is an software for the us doctors to keep the record of the patients for future refrences
1171408
Pharma companies make wayyy too much money on the "drug cocktail", the many drugs AIDS patients must take.  A cure means no one buys those drugs anymore.  It is in the best interest of their profit margin and their existense as a company that they never find a cure.
299515
Because the Medication may very well have a Depressant Effect Similar to Alcohol. Also, if the Medication in Question was Consumed Prior to Operation of Heavy Machinery, and an Accident were to Occur, with No Warning Stated on the Label, a Lawsuit against the Meds.Maker may Very Well Happen . The Lawyers are Out There!
641083
if u have been speking of Pharma industry in india i should be saying "it rocks". if u see the acquisitions amde by pharma it suggests that indian pharma r fast expanding and exploring into european and the US markets. the r&d expenditure was raised by all the pharma companies...almost all the top companies have some potentila patents in hands while most patents of the US companis will be expired by 2008-2010. this becomes a major advantage fo indian phrama companies which are known for generic and bulk drugs.\n\n\nso its hey day for indian pharma sector
1074338
I suggest you call your pharmacist and ASK. You should have been provided with information when the prescription was filled. If not, ASK FOR IT.
595659
I see some allegations on behalf of some people.  I found a document that says:\n\nI simple google search brings up a Mr. Swapan Banerjee from Ontario, and claims that he is filling suit in conjunction with his Permax treatment.  \n\nI just see a lof of talk that agonists (ie Permax, Mirapex, and Requip).  However, Permax appears to be talked about less.  I believe that Mirapex and Requip are prescribed more, so they would be the bigger fish.  I did not do a lot of research, but this is just conjecture from what I've heard.
583257
Roche pretty much ate igen up and igen stockholders are trading on a new company created by the merger, BioVeris.\n\nRead on:\n\n"IGEN announces merger with Roche completed\nTuesday, February 17, 2004 17:00 IST \nGaithersburg\n\nIGEN International Inc. announced that it has been acquired by Roche Holding Ltd and that IGEN will cease trading on The NASDAQ National Market.\n\nAs a result of the transaction, stockholders will receive $47.25 in cash, without interest, and one share of BioVeris Corporation common stock for each share of IGEN common stock they owned immediately prior to the closing. BioVeris common stock has been approved for listing on The NASDAQ National Market under the symbol "BIOV." Trading in BioVeris is expected to begin on February 17, 2004. \n\nOn July 24, 2003, IGEN and Roche jointly announced that they had entered into definitive agreements under which Roche would acquire IGEN and IGEN would simultaneously distribute the common stock of a new company, BioVeris Corporation, to its stockholders."
731182
recently there was a nes article in "the times of India" daily paper,\nthat the ingtriedients are not uniformly distributed in a tablet and the main medicine is mixed with binding agents, so breaking a tablet into two or grinding it into powder form does not reduces the dose concentration(i.e. gm per volume)rather in some cases like ibrufane , it can be harmful to intake broken tablet.\nbetter consult a doctor
321460
Check the secretary of state's website for wahtever state you think it was in.  Many of them maintain databases on corporate filings online now.   I've done this for other companies and it works fairly well, assuming you know either a.) what state they were incorporated in, or b.) in which state they had their principle place of business.
1178233
I hope you mean in a business context because that's how I am going to answer.  People need to be informed of progress to make intelligent decisions respecting potential investment into capital markets/equities.  \n\nExample: Oil companies report on drilling so that determination of reserves and possible renewed supplies can be made which in turn assist in evaluating the company doing the drilling by allowing them to restate their reserves.  Usually when a well hits the company stock will rise in value as a resuld of those increased reserves.\n\nExample: Drug companies always talk about where they are in clinical trials.  By doing that investors have an idea what new products to expect and can more intelligently determine weather the company is going in the right direction or not than invest accordingly.  When a drug has a successful testing series through the FDA and is approved than the company stock will generally benefit.