Generics Industry News Search
 |
|
|
|
|
|
|
May 2008 News Archive |
|
|
| |
|
Sepracor Inc. (Nasdaq: SEPR) today announced that it has entered into a Settlement and License Agreement with Breath Limited (Breath), an Arrow Group subsidiary, to resolve the patent litigation involving Sepracor's XOPENEX(R) brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg by the U.S. Food and Drug Administration. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Ahmedabad: Intas Biopharmaceuticals Ltd. (IBPL) signed a business agreement with Canada-based Apotex Inc. for co-development and supply of its Filgrastim brand, Neukine in North America (US and Canada)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Today, Fougera, a division of Nycomed US Inc., announced it has received FDA approval to bring to market the first generic Calcipotriene Topical Solution 0.005% (Rx) (Scalp Solution). The generic formulation compares to Dovonex(R) by Warner-Chilcott.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NEW YORK - Teva Pharmaceutical Industries Inc.'s first quarter net income fell 57%, reflecting an acquisition charge, as sales of multiple sclerosis treatment Copaxone rose 35%, at a pace the company doesn't expect to continue....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Drug maker Alchemia faces stiff competition for a new anti-clotting product but might still earn "reasonable income", an analyst report said.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Par Pharmaceutical Companies, Inc. today announced that it amended its agreement with Spectrum Pharmaceuticals, Inc. for $20 million in cash to increase its share of profits from the generic versions of GlaxoSmithKline's Imitrex Injection, which will be immediately accretive to 2008 earnings and provide a strong return on the Company's investment. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Amneal Pharmaceuticals is pleased to announce that it received US FDA approval to manufacture Primidone Tablets (50/250mg), Cyclobenzaprine Tablets (10mg) and Demeclocycline Tablets (150/300mg) within the last several weeks. Two of these products were filed during 2007 using the FDA's evolutionary eCTD/QbR/QOS format that enabled approvals in less than twelve months....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
COLUMBUS, Ohio - Roxane Laboratories Inc. announced today the approval of their Abbreviated New Drug Application for Acarbose Tablets, 25mg, 50mg, and 100mg....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceuticals is pleased to announce the introduction and availability of Ropinirole Hydrochloride Tablets. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The Federal Trade Commission and some lawmakers are attempting to prevent major pharmaceutical companies from paying generic drug makers to delay putting less expensive medicines on the market, saying the practice violates antitrust law....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ropinirole Hydrochloride Tablets, 0.25 mg (base), 0.5 mg (base), 1 mg (base), 2 mg (base), 3 mg (base), 4 mg (base) and 5 mg (base)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
TORONTO: Four years after it was passed unanimously by Parliament, a bill drafted to allow low-cost Canadian-made AIDS drugs to be exported to developing countries may be on the verge of finally producing results.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The decentralized approval procedure of clopidogrel, developed by Cimex AG (original product: Plavix/Iscover by Bristol-Myers Squibb/Sanofi-Aventis), has successfully been completed....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Barr needs a shot of good medicine as analysts and investors lose confidence in the pharmaceutical company....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Hi-Tech Pharmacal Co. Inc. announced today that it entered into a distribution and supply agreement with a subsidiary of Warner Chilcott Limited to market the authorized generic version of Warner Chilcott's Dovonex(R) Scalp Solution (calcipotriene solution 0.005%)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MONTVALE, N.J.: Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin(R) (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan has decided to sell its emergency-treatment business in an effort to protect its other assets, namely, its generic drug business. Meanwhile, elsewhere in generic-land, some did well, some disappointed and all of them are giving Big Pharma a run for its money....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
U.S. traded shares of French drug maker Sanofi-Aventis fell Friday after a rival said it is preparing to start selling a generic version of Sanofi's anti-clotting drug Plavix.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
IRVINE, California: Spectrum Pharmaceuticals Inc., announced today that it has sold its abbreviated new drug applications (ANDAs) for its injectable generic drugs, ondansetron, carboplatin, fludarabine, and mitoxantrone, to Sagent Pharmaceuticals, Inc....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
We previously reported on FDA efforts to resolve 180-day exclusivity forfeiture issues concerning generic versions of Bayer Pharmaceuticals' diabetes drug Precose (Acarbose) Tablets establishing a public docket. The FDA has also taken similar actions to resolve 180-day exclusivity issues concerning Ramipril and Granisetron....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
In February 2006, the U.S. District Court for the Southern District of New York determined that Takeda's patent on pioglitazone, the active ingredient in Actos, is neither invalid for obviousness nor unenforceable due to inequitable conduct.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Sanofi-Aventis and partner Bristol-Myers Squibb are ready to battle for the patents on their blockbuster blood-thinner Plavix, which are being threatened in Germany. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
LONDON - A coming wave of Chinese pills is set to push down the price of generic drugs, as more low-cost finished medicines from the country win approval in major markets, according to a report on Tuesday....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Simcere Pharmaceutical Group , a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endu in China, today announced that it has received approval from the Chinese State Food and Drug Administration (SFDA) to manufacture and market a first- to-market generic Biapenem injection under the brand name Anxin.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
BRUSSELS: European antitrust investigators are expanding the scope of a major inquiry into the 484 billion euro pharmaceutical market in a bid to determine whether companies are blocking generics makers from getting less-expensive medicines to market quickly.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Just when Sanofi-Aventis (NYSE: SNY) seemed finally free of generic threats against its top drugs, new worries have now popped up. Since Friday, Sanofi's shares have fallen more than 4% after a new potential generic challenger to one of its lead drugs surfaced....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
AstraZeneca PLC said Wednesday that U.S. regulators have approved its anti-psychotic drug Seroquel as a maintenance treatment for patients with a type of bipolar disorder....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that Salix Pharmaceuticals, Inc.; Norgine, B.V. and Norgine Europe, B. V. have filed a lawsuit in the United States District Court for the District of New Jersey against Novel Laboratories, Inc. for infringement of Norgine's patent protecting MOVIPREP(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution). Norgine licensed MOVIPREP to Salix for commercialization in the United States.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Concern is growing that patents hinder access to life-saving drugs in developing countries. While India clearly has made progress in advancing intellectual property rights, more needs to be done to align the country's approach with international obligations and standards. In an interview with India Knowledge@Wharton, Ranjit Shahani, country president of the Novartis Group in India, spoke about the importance of safeguarding intellectual property and its impact on affordability and access to medicine. Novartis is challenging the denial of a patent for its cancer drug Glivec, as it is known in India. (In the U.S., the drug is called Gleevec.) ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
KV Pharmaceutical Company , a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology-differentiated branded products and generic/non-branded prescription pharmaceuticals, announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) to market its 50 mg strength of metoprolol succinate extended-release tablets. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
APP Pharmaceuticals, Inc. is communicating in a letter to its customers that the company continues to work closely with the U.S. Food and Drug Administration (FDA) to ensure that an uninterrupted and safe supply of heparin of the highest quality is available for U.S. patients....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Lannett Company Inc., a manufacturer of generic pharmaceuticals, said today that it continues to work closely with the U.S. Food and Drug Administration (FDA) to ensure that an uninterrupted and safe supply of Digoxin Tablets is available for U.S. patients, following the FDA's announced recall of Digitek brand of Digoxin.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
TORONTO - Biovail Corporation today announced that a subsidiary of the Company has reached an agreement with the United States Department of Justice (DOJ) in respect of criminal allegations related to activities surrounding the 2003 commercial launch of Cardizem(R) LA....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan Inc. announced that Mylan Pharmaceuticals Inc. has launched Paroxetine Hydrochloride (HCl) extended-release (ER) tablets, the generic version of GlaxoSmithKline's (GSK) Paxil CR. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The CAFC affirmed a ruling that the Lovenox patents - owned by Aventis - are unenforceable due to a failure to submit important experimental information during prosecution. In dissent, Judge Rader could not find clear and convincing evidence of intent to deceive the PTO....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
In two separate rulings, The United States Patent & Trademark Office announced that it will revoke both patents on the epilepsy drug felbamate. The rulings are the latest problems for a drug haunted by controversy since its inception....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NEW YORK - Spear Pharmaceuticals Inc. received FDA approval for, and began shipping, Fluorouracil Cream 5%, USP, a generic equivalent to Valeant's Efudex(R) Cream....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceuticals announces the introduction and availability of Ropinirole hydrochloride Tablets, 5 mg....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Perrigo Co. says it has entered a collaborative agreement to develop generic drugs with Cobrek Pharmaceuticals, a privately owned company that specialises in the research and development of niche generic products.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
After Teva launched generic Protonix on Christmas Eve, fought with Wyeth about it, then made a surprise exit, we thought the drama was over. But this week we get another act, thanks to the the injectable form of the drug Wyeth sells as Protonix I.V....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
India's Dabur Pharma Ltd. said the U.S. Food and Drug Administration (FDA) has given it final approval for the abbreviated new drug application (ANDA) to market the generic version of EMD Serono's Novantrone or Mitoxantrone Hydrochloride injection....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Novartis's ongoing stoush with the Madras High Court in India created quite a stir on the world stage late last year. It concerns the patentability of the beta crystalline form of Imatinib, the active pharmaceutical ingredient in the blockbuster drug Gilvec (Gleevec)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The new leader for the UK generics industry has promised to step up its bid to see more off-patent drugs used in the NHS. Generics are vital for an affordable health service and play a role in boosting innovation, according to the newly appointed chairman of the British Generic Manufacturers Association (BGMA) Kim Innes....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Ranbaxy Laboratories Limited, India's largest pharmaceutical company and among the top 10 global generics companies in the world, commenced its operation in Yemen, introducing its products to around 350 doctors.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Biopharmaceuticals, such as Epogen (epoetin) and Erbitux (cetuximab), are becoming increasingly important for the treatment of disease. U.S. sales of such drugs were about 40 billion in 2006 and are expected to rise to over 90 billion in 2009. Accordingly, political pressure is building to allow the sale of 'biosimilar' drugs....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Title XI (1112) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ('MMA') requires pharmaceutical applicants (both brand and generic) to file with the Federal Trade Commission ('FTC') and the Assistant Attorney General certain agreements executed on or after January 7, 2004....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Inflated prices on generic prescription drugs mean B.C.'s Pharmacare program and drug consumers are paying hundreds of millions of dollars more for medications than they should be each year, says former auditor-general George Morfitt, a member of a committee asked by the provincial government to identify drug funding and approval reforms.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
New Delhi: A day before member nations of the World Health Organization, or WHO, meet in Geneva to discuss measures needed to deal with the increasing incidence of counterfeit drugs, the Indian government and public health activists have strongly opposed adopting a broad definition of such medicines and the steps to tackle their growing availability in global markets....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Brand name pharmaceutical companies struck 14 deals that led to delayed sale of cheaper generic drugs in the 2007 fiscal year, the U.S. Federal Trade Commission said.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Akorn-Strides, LLC today announced the approval of an ANDA for Rifampin for Injection USP, 600 mg/vial. This is the first lyophilized Injectable product approval for the Joint Venture....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
An increase in the number of prescription drugs filled with generic equivalents has saved the Public Employees Insurance Agency nearly $11 million so far this budget year....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Members of the World Health Organisation agreed a global strategy at the weekend that opens the way for innovative schemes to promote research into drugs to treat diseases common in poor nations....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The US government plans to plug a loophole in its laws to prevent patent deals between drug companies and generics makers, many of them from India, that appear to delay availability of cheaper, non-patented versions to American patients....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Osmotica Pharmaceutical has received notice of final approval for its venlafaxine hydrochloride extended-release 37.5mg, 75mg, 150mg and 225mg tablets NDA from FDA for major depressive disorder and social anxiety disorder....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure. Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Last week, the governing assembly of the World Health Organization held its annual summit in Geneva. The two big items on the agenda were finalising and approving a report recently released by the WHO's international public health subcommittee....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The National Medicinal Drug Policy (NMDP) has been, it appears been dealt a near fatal blow by the combined efforts of the Pharmaceutical industry and a section of the medical establishment including the SLMC and SLMA and its appendages....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Barr Pharmaceuticals Inc. today confirmed that its subsidiary, Barr Laboratories Inc., has initiated a challenge of the patents listed by AstraZeneca LP in connection with its Entocort(R) Enteric Coated Capsules (budesonide), 3mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Entocort EC....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
One of the nation's largest pharmacy benefits management companies has reached a multi-state settlement, resolving claims of deceptive business practices....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
India's Aurobindo Pharma Ltd. said it has received its final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market benazepril hydrochloride tablets, used for treatment of hypertension.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Generic drug maker Impax Laboratories Inc. had its stock registration revoked by the Securities and Exchange Commission. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
LifeCycle Pharma A/S (OMX:LCP) today announced the successful completion of pilot studies for LCP-Feno, a product for the treatment of dyslipidemia which is being developed in collaboration with Sandoz Inc. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Cimex AG received the first approval from the BfArM (Federal Institute for Drugs and Medical Devices, Germany) for the antiplatelet agent clopidogrel. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Pfizer Inc said today that the Australian Full Federal Court in Victoria has upheld on appeal the exclusivity of its basic patent covering atorvastatin, the active ingredient in Lipitor. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Taro Pharmaceutical Industries Ltd. today announced that its Board of Directors unanimously voted to terminate the May 18, 2007 merger agreement between the Company and Aditya Acquisition Company Ltd., a subsidiary of Sun Pharmaceutical Industries Ltd....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Sun Pharmaceutical Industries Ltd. today sent a letter to Barrie Levitt, MD, chairman of Taro Pharmaceutical Industries Ltd regarding Taro's purported termination of the May 18, 2007 merger agreement with Sun.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
India's Lupin, which had won a patent challenge case against US-based King Pharmaceuticals and Sanofi-Aventis for blood pressure drug Altace will now have to do a rethink over the launch of its generic version in the US. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
UCB SA, the Belgian maker of the allergy medicine Zyrtec, and Sepracor Inc. sued Sun Pharmaceutical Industries Ltd. to block sales of a generic version of the antihistamine Xyzal in the U.S....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Bruce Downey seems cheerful for a guy who just watched his net worth drop by US 5 million dollars. Downey is the chief executive officer of generic drugmaker Barr Pharmaceuticals, and he owns about 424,000 shares of the stock....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Glenmark Generics Limited (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), has received ANDA approvals for Mometasone Furoate Ointment USP, 0.1%, Mometasone Furoate Cream USP, 0.1% and Metformin Hydrochloride Tablets USP 500 mg, 850 mg and 1000 mg and will soon commence marketing and distribution of these products in the US market....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Lupin Pharmaceuticals Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Washington - Biotech drugmaker Genzyme Corp. spent 640,000 USD lobbying the federal government in the first quarter, according to a disclosure form....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceutical Industries Ltd. announced today that it has begun commercially shipping Bupropion Hydrochloride Extended-Release Tablets, 150 mg, the generic version of Biovail Corporation's antidepressant Wellbutrin XL Tablets, pursuant to its March 2007 agreement with Anchen Pharmaceuticals Inc....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Genpharm ULC, one of Canada's top five generic pharmaceutical companies, today announced that it has won a significant legal victory in Quebec's Superior Court....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceuticals is pleased to announce the introduction and availability of Cetirizine Hydrochloride Syrup....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched amifostine for injection 500mg on behalf of Sun Pharmaceutical Industries Ltd....
|
| |
|
|
Read more >>
|
| |
|
|
|
|
|
Contribute
If you would like to contribute or publish your
company press releases at GenericsWeb, please
email us.
|
Home
