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Generics
Indian drugmaker Cipla is recalling 4,800 bottles of nevirapine extended-release tablets used for the treatment of human immunodeficiency virus (HIV) from the American market, according to a report by the US health regulator. 31 December 2018
Generics
The US Food and Drug Administration yesterday published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.” 21 December 2018
Generics
The US Food and Drug Administration is publishing interim acceptable intake levels of nitrosamine impurities in angiotensin II receptor blockers (ARBs) for manufacturers to use to ensure their finished drug products are safe for patients. 20 December 2018
Generics
India’s Zydus Cadila has received the final approval from the US Food and Drug Administration to market albendazole tablets 200mg. 17 December 2018
Generics
London-headquartered Hikma Pharmaceuticals’ US subsidiary has launched clobazam oral suspension, 2.5mg/mL, and clobazam tablets, 10mg and 20mg, the generic equivalent to Onfi, which is marketed by Danish CNS specialist Lundbeck. 10 December 2018
Generics
The US Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines. 10 November 2018
Generics
India’s Zydus Cadila has received the tentative approval from the US Food and drug administration for sitagliptin tablets USP, 25mg, 50mg and 100mg. 11 September 2018
Generics
Shares of Teva Pharmaceutical Industries were down 1.1% at $21.50 by close of New York trading on Friday, after the US Food and Drug Administration announced that it had approved the Israeli generics giant’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. 8 September 2018
Generics
Alvogen today announced that it has successfully concluded multiple registration applications for Gefitinib tablets. 5 September 2018
Generics
Indian drugmaker Lupin announced today the completion of a current Good Manufacturing Practices (cGMP) inspection carried out by the US Food and Drug Administration at its Tarapur facility. 4 September 2018
Generics
China’s medicines regulator has give approval for the drug approval application for the country's first genetic version of UK pharma major GlaxoSmithKline’s Volibris (ambrisentan), a treatment for pulmonary arterial hypertension (PAH). 23 August 2018
Generics
In the ongoing worldwide recall of an off-patent blood pressure drug, another manufacturer has been added. 21 August 2018
Generics
The US Food and Drug Administration is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that China-based Sichuan Friendly Pharmaceutical is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. 18 August 2018
Generics
The US subsidiary of Indian drugmaker Cipla has secured rights from MSN Laboratories to market and distribute capecitabine 150mg and 500mg tablets in the USA. 14 August 2018
Generics
In a strategic move, Cadila Healthcare, an Indian healthcare provider, announced that it will be acquiring 51% stake in Dehradun-based Windlas Healthcare, with not financial terms of the deal provided. 13 August 2018
Generics
Indian generics giant Sun Pharma has announced the launch of a new generic equivalent to the diabetes drug Glumetza (metformin hydrochloride) in the US. 25 July 2018
Generics
Beximco Pharmaceuticals, a Bangladeshi company with a focus on generic medicines, has announced the launch of its Glucophage (metformin hydrochloride) equivalent in the USA. 23 July 2018
Generics
The US Food and Drug Administration today posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for abuse-deterrent formulations (ADF) opioid products. 20 July 2018
Generics
Jordan-based generic drugmaker Hikma Pharmaceuticals says it US business has begun releasing significant quantities of hydromorphone to US hospital customers to help ease a current shortage of injectable opioids used to treat patients. 18 July 2018
Generics
UK-headquartered Indivior today announced that the US District Court for the District of New Jersey has granted a preliminary injunction (PI) against Indian generic drugmaker Dr Reddy's Laboratories. 14 July 2018
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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