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Generics
Indian pharma major Lupin has received final approval for its Oseltamivir Phosphate for Oral Suspension from the US Food and Drug Administration to market the generic version of Swiss pharma giant Roche’s Tamiflu for Oral Suspension, 6mg/mL. 22 February 2018
Generics
US-based CASI Pharmaceuticals has bought a portfolio of 25 US FDA-approved abbreviated new drug applications (ANDAs), one ANDA that FDA tentatively approved, and three that are pending FDA approval. 31 January 2018
Generics
Fresenius Kabi, a company specializing in medicines and technologies for infusion, transfusion and clinical nutrition, has announced the US availability of injectable remifentanil hydrochloride, an opioid analgesic drug. 30 January 2018
Generics
Ireland-incorporated Endo International has agreed to a request by the US Food and Drug Administration to seek a temporary stay of the litigation initiated against the FDA in October 2017 by the company's subsidiaries, Par Sterile Products and Endo Par Innovation. 25 January 2018
Generics
Some generic drugmakers in the USA have come under modest pressure in apparent response to a speech delivered by US Department of Justice antitrust division chief Makan Delrahim on Friday at George Mason University's law school. 20 January 2018
Generics
Ireland-incorporated Endo International has received a grand jury subpoena from the US Attorney's Office for the Southern District of Florida seeking documents and information relating to products containing oxymorphone. 11 January 2018
Generics
Following the retirement of John Hendrickson, Ireland-incorporated generic and OTC drugmaker Perrigo has appointed Uwe Röhrhoff as president and chief executive, effective January 15, 2018. 8 January 2018
Generics
Israeli drugmaker Teva has announced the launch of an authorized generic of Estrace Cream (estradiol vaginal cream, USP, 0.01%) in the USA. 3 January 2018
Generics
Israeli drugmaker Teva Pharmaceutical Industries has wasted no time in launching a generic version of a newly off-patent HIV drug with annual US sales of around $762 million. 18 December 2017
Generics
Israeli generics giant Teva Pharmaceutical Industries announced the exclusive launch of its generic Viagra (sildenafil citrate) tablets in the USA. 13 December 2017
Generics
Mylan has announced that Teva Pharmaceutical Industries has dismissed its pending district court litigation against Mylan regarding its glatiramer acetate injection 40mg/mL, the first generic version of Copaxone 40 mg/mL. 12 December 2017
Generics
India’s Strides Shasun, formerly Strides Arcolab, has entered an agreement for the sale of its branded generic business to Eris Lifesciences for an aggregate cash consideration of Rupees 500 crore (around $77.48 million), sending the shares of Strides up 3.36% to 813.50 rupees, while Eris leapt 6.92% to 625.00 rupees. 20 November 2017
Generics
The US Patent & Trademark Office (PTO) has granted Argentum Pharmaceuticals’ petition for inter partes review (IPR) against all patent claims in the first patent listed in the Food and Drug Administration's Orange Book as covering Canadian drugmaker Valeant Pharmaceuticals International's Jublia (efinaconazole topical solution 10%), which is FDA-approved for the treatment of onychomycosis of the toenails. 14 November 2017
Generics
Billionaire businessman Len Blavatnik is looking to buy an up to $3 billion stake in Teva Pharmaceutical Industries, according to media reports, including the Israeli business newspaper Globes. 6 November 2017
Generics
Swiss pharma giant Novartis is considering selling its dermatology generics business, Bloomberg reports. 2 November 2017
Generics
Teva Pharmaceutical Industries today announced that the US District Court for the District of Delaware has ruled in the company's favor in patent litigation involving Teva's Abbreviated New Drug Application (ANDA) directed to a generic version of Valeant Pharmaceutical International's Uceris (budesonide ER) tablets. 31 October 2017
Generics
The US Food and Drug Administration has released a series of brief video presentations for industry explaining new features of the Generic Drug User Fee Amendments (GDUFA). 27 October 2017
Generics
The US Food and Drug Administration (FDA) has published 51 product-specific guidances (47 new and four revised) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs. 20 October 2017
Generics
Impax Laboratories and Amneal Pharmaceuticals are close to a merger agreement, The Wall Street reported on Monday. 17 October 2017
Generics
Today, the US Food and Drug Administration published the draft guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” 16 October 2017
Generics
This article explores the latest conversations around generic topical and transdermal drug delivery systems (TDS) in the US Food and Drug Administration’s (FDA dermal pharmacology space, delving into recent guidance updates and examining the challenges facing the development of generic TDS. 21 January 2025
Generics
Several of the USA’s biggest pharmacy benefit managers (PBMs) have generated billions of dollars in revenue by charging “enormous mark-ups,” according to the competition regulator. 15 January 2025
Generics
Swiss pharma giant Novartis has expressed its satisfaction at a decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto (sacubitril/valsartan) combination patent. 14 January 2025
Generics
India's Parliamentary panel has come down heavily on the National Pharmaceutical Pricing Authority (NPPA) and directed it to provide a detailed report explaining the recent 50% price increase on 11 essential drug formulations. 30 December 2024
Generics
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
Generics
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Generics
The US Court of Appeals for the Federal Circuit on Friday affirmed a lower district court order against Israeli pharmaceutical maker Teva Pharmaceutical Industries requiring its US subsidiary to delist several asthma inhaler patents from the Food and Drug Administration’s (FDA) Orange Book. 23 December 2024
Generics
Venture capital firm BC Partners has entered into an agreement under which the private equity business at Goldman Sachs Alternatives will acquire a majority stake in Netherlands-based Synthon, from funds advised by BC Partners. 17 December 2024
Generics
Swiss generic and biosimilar medicines major Sandoz today announced a number of steps to resolve the US Generic Drug Antitrust Class Action Litigation. 17 December 2024
Generics
Shares of Swedish pharma firm Orexo leapt 20.2% to 20.60 kronor this morning, following its announcement over the weekend that is has reached a settlement agreement with India’s Sun Pharmaceutical Industries to resolve the patent litigation regarding Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII), for the treatment of opioid use disorder in the USA. 16 December 2024
Generics
Israeli drugmaker Teva Pharmaceutical Industries has entered into an agreement with JKI - established by the fund managed and operated by J-Will - whereby all shares of Teva Takeda Pharma Limited and its wholly-owned subsidiary, Teva Takeda Yakuhin, will be transferred to JKI. 6 December 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Generics
Indian drugmaker Aurobindo Pharma has taken on the might of China in terms of Penicillin G pricing, and is doing so by leveraging a fully integrated production process at its new plant. Anticipating the price erosion of Penicillin G, the company has put up an integrated plant from scratch. 10 November 2024
Generics
Indian markets are abuzz with a singular refrain. Donald Trump's Presidency of the United States is set to open new opportunities for India, especially in the pharmaceutical sector. 8 November 2024
Generics
US generic drugmaker Viatris announced robust financial results for the third quarter of 2024, driven by positive momentum against all three pillars of its strategy. The company’s shares shot up 13.5% to $13.18 following the announcement. 8 November 2024
Generics
Teva Pharmaceutical Industries’ shares were up 4% at 7,323 shekels today reported results for the quarter ended September 30, 2024. 6 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Generics
Swiss biosimilars and generics group Sandoz today reported net sales for the third quarter ended September 30, 2024. 30 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
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