Generics Industry News Search
 |
|
|
|
|
|
|
May 2013 News Archive |
|
|
| |
|
Actavis and Valeant today announced that Actavis Specialty Brands has acquired worldwide rights to Valeant's Metronidazole 1.3% Vaginal Gel antibiotic development product, a topical antibiotic for the treatment of bacterial vaginosis...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Prasco announced today it has signed an exclusive distribution and supply agreement with WellSpring for Phenoxybenzamine hydrochloride capsules, USP...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Claris Lifesciences announced today that it has received an ANDA approval for Metoprolol tartrate injection; having strength of 1 mg / ml in 5ml glass vials in the USA...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Aurobindo has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Tamsulosin hydrochloride capsules USP 0.4mg (ANDA 202433) and Clindamycin palmitate hydrochloride for oral Solution USP (Pediatric), 75mg (base)/5mL (ANDA 202409)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
A survey of drug manufacturers finds that brand teams frequently wait until 2 years prior to patent expiration before planning for generic entrants...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
India's top drug makers, among the world's biggest producers of cheap generic medicines, are looking beyond their own shores to generate revenue, seeking to profit from big-selling drugs going off-patent this year in the lucrative U.S. market...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Oncobiologics announced today that Zhejiang Huahai and Oncobiologics have signed an alliance agreement for the development, manufacture and commercialisation of biosimilar monoclonal antibody products...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Giant Eagle claims in a federal antitrust lawsuit filed Wednesday in Pittsburgh that AstraZeneca and three generic drug makers conspired to delay the availability of generic versions of Nexium so that the London-based company could maximise its profits on the stomach medicine...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis, today confirmed that the United States District Court for the Southern District of Florida has found United States Patent No. 6,773,720 (the '720 Patent) valid and infringed by Actavis' generic version of Shire's Lialda (Mesalamine extended-release tablets)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Warner Chilcott today announced that the United States Food and Drug Administration (FDA) has approved a new oral contraceptive, Norethindrone acetate and Ethinyl estradiol chewable tablets and ferrous fumarate tablets, for the prevention of pregnancy...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis, a global specialty pharmaceutical leader, today confirmed that Actavis has entered into early stage discussions with Warner Chilcott regarding a potential combination of the two companies...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The original formulation of extended-release Oxymorphone (Opana ER) that lacked abuse-resistant mechanisms was not pulled from the market for safety reasons, and therefore generics based on that recipe are permissible, the FDA said...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
ScinoPharm Taiwan and Coland holdings announced today that they have formed a strategic alliance to develop a series of generic oncological drugs for Mainland China...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The generic drug maker Ranbaxy pleaded guilty on Monday to federal drug safety violations and will pay $500 million in fines to resolve claims that it sold subpar drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India, the company and federal prosecutors announced Monday...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Arbor announced today that the U.S. Food and Drug Administration has approved its New Drug Application for Nymalize (Nimodipine) oral solution...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
AstraZeneca sued Actavis in New Jersey federal court Friday to block the generic-drug maker from selling a version of the arthritis drug Vimovo
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva on Monday defended its patent suit over rival Sandoz's attempt to develop a generic version of its multiple sclerosis drug Copaxone, saying legal safe harbors that protect generic development do not apply in this case....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Sanofi has been fined by the French Competition Authority for "disparaging" generic copies of its now-off-patent bloodthinner, Plavix...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis rejected a cash-and-stock offer from fellow generic drugmaker Mylan for $15 billion, deciding instead to pursue talks to take over Warner Chilcott, said people familiar with the matter...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Zolmitriptan Tablets, 2.5 mg and 5 mg...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Glenmark Generics, USA has been granted final abbreviated new drug approvals from the United States Food and Drug Administration for Zolmitriptan tablets, 2.5 and 5mg and Zolmitriptan orally disintegrating Tablets, 2.5 and 5mg. Glenmark will commence distribution of the product immediately...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Canada's Supreme Court dismissed Eli Lilly's request to appeal a federal court decision that invalidated its Canadian patent for schizophrenia drug Zyprexa...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Impax today announced that its generics division, Global Pharmaceuticals, commenced shipment of authorised generic Zomig (Zolmitriptan) tablets and orally disintegrating tablets, 2.5 mg and 5 mg, in the U.S., as part of a Distribution, License, Development and Supply Agreement with AstraZeneca...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan today announced that its subsidiary has shipped Fenofibrate tablets, 48 mg and 145 mg...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Senju, Kyorin and Allergan hit Strides Inc. and Agila Specialties with a patent infringement lawsuit in Delaware federal court Wednesday over their plans to market a generic version of Allergan's Zymar and Zymaxid conjunctivitis eye drops...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
AbbVie on Wednesday hit Hetero in Delaware federal court with allegations that the generics maker infringes several patents with its planned generic version of HIV treatment Norvir...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
A federal judge on Monday refused to dismiss multidistrict litigation accusing Pfizer Inc.'s King Pharmaceuticals Inc. and Mutual Pharmaceutical Co. Inc. of keeping generic versions of the muscle relaxer Skelaxin off the market, finding Rite Aid Corp....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis and Warner Chilcott today announced they have entered into a definitive agreement under which Actavis will acquire Warner Chilcott in a stock-for-stock transaction valued at approximately $8.5 billion...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
A U.S. federal court on Monday ruled in favour of Cubist Pharma on the interpretation of patent language in a case involving a generic challenge to its lead drug Cubicin by Hospira...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis, the largest U.S. maker of generic drugs by market value, agreed to acquire Warner Chilcott for about US$5-billion excluding net debt in a deal to expand in women's health and urology
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The EMA has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan today announced that the Court of Appeals for the Federal Circuit has ruled in favour of Mylan Specialty, formerly Dey Pharma, and has reversed the District Court's decision invalidating five of Mylan's patents related to Perforomist...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Sanofi won a U.S. appeals court ruling yesterday that revives a patent-infringement claim over generic versions of the allergy drug Allegra...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Indian generic giant Ranbaxy said Wednesday it has spent over $300 million to overhaul its operations and ensure no repeat of drug safety violations that led to a multimillion-dollar U.S. fine...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Par today announced that it has entered into an exclusive U.S. supply and distribution agreement with AstraZeneca to distribute the authorised generic version of AstraZeneca's Atacand (Candesartan cilexetil)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
A New Jersey federal judge on Thursday dismissed Teva's claims that generic-drug makers Watson and Apotex infringed its patents for the Parkinson's disease drug Azilect, saying the parties have reached confidential settlement and licensing agreements....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, is recalling multiple lots of three of its drugs from the US market due to "odd smell", according to US FDA...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Tightening noose with additional scrutiny on ANDAs from India will cause further delay in approval of drugs...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis today confirmed that the United States Court of Appeals for the Federal Circuit has granted a motion by AstraZeneca to enjoin Actavis from further distribution of its generic version of AstraZeneca's Pulmicort Respules (Budesonide inhalation suspension) 0.25, 0.5 mg products, pending resolution of AstraZeneca's appeal before the Court...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
A subsidiary of Fresenius on Thursday accused the Indian pharmaceutical company Dr. Reddy's and a U.S. unit of infringing four of its patents when Dr. Reddy's applied to produce a generic version of the sedative Diprivan...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The American company Pfizer, the world's largest pharmaceutical company, recently filed a civil suit in Tel Aviv District Court, seeking monetary relief to the tune of NIS10 million (over $2,700,000) as well as extensive equitable relief in the forms of a permanent injunction, a writ of mandamus and accounting, against Unipharm of Tel Aviv and Trima of Ma'abarot...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Are antitrust regulators unfairly targeting Big Pharma's patent settlements? As the debate rages on--and continues to spread--more experts and pharma execs are pushing back, the Financial Times reports...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Sun today announced that it has received final approval from the USFDA for its abbreviated new drug application for generic version of Depo-Testosterone Injection, Testosterone Cypionate Injection USP, 100 mg/ml and 200mg/ml...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Perrigo today announced that it has received final approval for the generic version of Sanctura...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Perrigo Company announced that it has filed an ANDA with the U.S. FDA for testosterone topical solution, the generic version of Axiron Topical Solution...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Legislation to enable the introduction of reference pricing and pro-generic initiatives has now been passed by both houses of Ireland's parliament (Oireachtas) and is expected to take effect next month...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
It didn't take long for a generic company to challenge the patent-worthiness of Eli Lilly's new drug for treating low Testosterone...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Avanir on Thursday sued Sandoz in Delaware to block its attempt at marketing a generic version of involuntary-emotion drug Nuedexta, claiming Sandoz's copycat drug would infringe its patents...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Shire has settled its litigation against Teva in connection with Teva's Abbreviated New Drug Application (ANDA) for a generic version of Shire's Intuniv (Guanfacine) extended release tablets for the treatment of attention deficit hyperactivity disorder...
|
| |
|
|
Read more >>
|
| |
|
|
|
|
|
Contribute
If you would like to contribute or publish your
company press releases at GenericsWeb, please
email us.
|
Home
