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Generics
Not long after receiving a Form 483 warning from the US regulator in relation to its Bollaram, India-based site, Dr Reddy’s said another Active Pharmaceuticals Ingredients (API) plant is set for a reinspection, this time at Srikakulam in Andhra Pradesh. 2 August 2019
Generics
Alvogen subsidiary Lotus Pharmaceuticals has launched vinorelbine 20, 30 and 80mg soft capsules in Europe, it was announced today. 1 August 2019
Generics
The first UK product launches are underway for German central nervous system (CNS) specialist Neuraxpharm, guided by new UK general manager Craig Bowen. 31 July 2019
Generics
As of September 15, Eelco Ockers will strengthen the global German drugmaker Stada Arzneimittel’s executive committee as executive vice president Germany. 27 June 2019
Generics
Swiss pharma giant Novartis has been granted an injunction preventing generic versions of its top-selling drug from entering the US market. 25 June 2019
Generics
China's National Health Commission has listed 34 drugs that it sees as in need of generic version. 24 June 2019
Generics
Amphastar Pharmaceuticals has entered into an agreement which will see Momenta Pharmaceuticals and Novartis’ US-based generics arm Sandoz pay nearly $60 million to settle ongoing litigation. 20 June 2019
Generics
Israeli generics company Teva Pharmaceutical Industries has launched a copy of Ranexa (ranolazine) in the USA. 29 May 2019
Generics
SE Asian demand for manufacturing is being driven by recent regulatory changes and increased generics from Indonesia, Malaysia and the Philippines. 1 May 2019
Generics
Israeli drugmaker Teva Pharmaceutical Industries has launched a generic version of the overactive bladder (OAB) drug VESIcare (solifenacin succinate) in the USA. 23 April 2019
Generics
Ireland-headquartered drugmaker Endo International has started shipping an approved generic of Merck & Co’s Proventil (albuterol sulfate) HFA inhalation aerosol to the USA. 5 April 2019
Generics
Zydus Cadila has received tentative approval from the US regulator to market Myrbetriq (mirabegron), an extended-release formulation selective beta 3-adrenoceptor agonist. 3 April 2019
Generics
The US Food and Drug Administration has approved multiple generics for Letairis (ambrisentan) tablets, a treatment for pulmonary arterial hypertension (PAH) originated by biotech major Gilead Sciences, 1 April 2019
Generics
The US Food and Drug Administration has updated the summary table forms for abbreviated new drug application submissions containing clinical endpoint studies. 12 February 2019
Generics
Following US Food and Drug Administration approval in late 2018, Slayback Pharma says that it has now launched its first commercial product hydroxyprogesterone caproate injection, USP 1,250mg/5 ml. 22 January 2019
Generics
The US Food and Drug Administration (FDA) has published draft guidance for generic drug developers. 18 January 2019
Generics
US-based generics firm Sandoz, a Novartis division, has launched Symjepi (epinephrine) for the emergency treatment of allergic reactions in the USA. The firm says the product will be an “affordable, single-dose, pre-filled syringe alternative to epinephrine auto-injectors.” 17 January 2019
Generics
Nexus Pharmaceuticals says that the US Food and Drug Administration has approved busulfan injection, the company's AP-rated therapeutic equivalent for Busulfex 60mg/10mL (6mg/1mL), originated by USA-based PDL BioPharma. 17 January 2019
Generics
USA-based Amneal Pharmaceuticals today announced that it has received US Food and Drug Administration approval for a generic version of Exelon Patch (rivastigmine transdermal system). 14 January 2019
Generics
Illinois Attorney General Lisa Madigan says she has recovered $135 million for the state of Illinois in a settlement with the US subsidiary of Israeli generics giant Teva Pharmaceutical Industries that resolves allegations the drug company inflated the wholesale prices used in setting the rates for Medicaid reimbursements. 12 January 2019
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
Generics
The US Food and Drug Administration (FDA) yesterday published the guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.” 17 October 2024
Generics
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Generics
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Generics
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Generics
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
Generics
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
Generics
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
Generics
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Generics
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
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