Aurobindo Pharma's US branch issues a recall of a generic medicine – Endpoints News

In­di­an gener­ics man­u­fac­tur­er Au­robindo is hav­ing to pull an­oth­er prod­uct off the shelves.
Ac­cord­ing to the FDA, the com­pa­ny’s US branch, Au­robindo Phar­ma USA, has is­sued a vol­un­tary re­call of two batch­es of the heart med­ica­tion Quinapril. The re­call was is­sued over a “Ni­trosamine Drug Sub­stance Re­lat­ed Im­pu­ri­ty” above the pro­posed lim­it.
Ni­trosamines, an or­gan­ic chem­i­cal com­mon in wa­ter or foods, can in­crease the risk of can­cer if peo­ple are ex­posed to them over an ex­tend­ed pe­ri­od. The FDA re­port­ed that Au­robindo Phar­ma USA has not re­ceived any re­ports of ad­verse ef­fects re­lat­ed to the re­call.
The FDA ad­vis­es pa­tients tak­ing Quinapril to con­sult a physi­cian or a health­care provider as to whether they should con­tin­ue tak­ing the drug or if an al­ter­na­tive needs to be sourced.
The FDA an­nounce­ment said:
“Qualanex, on be­half of Au­robindo Phar­ma USA, Inc., will be no­ti­fy­ing its dis­trib­u­tors and cus­tomers by phone and in writ­ing to im­me­di­ate­ly dis­con­tin­ue dis­tri­b­u­tion of the spe­cif­ic lots be­ing re­called and to no­ti­fy their sub-ac­counts,”
Au­robindo is al­so ar­rang­ing for the re­turn of all re­called prod­ucts as well.
Any gen­er­al ques­tions re­gard­ing the re­call should con­tact this num­ber: 1-888-504- 2014, and any ad­verse ef­fects may be re­port­ed to the FDA’s Med­Watch Ad­verse Event Re­port­ing pro­gram.
Ni­trosamines have man­aged to pull prod­ucts off the shelves be­fore. Last year, Pfiz­er’s an­ti-smok­ing drug Chan­tix was re­called at a wide rate over el­e­vat­ed lev­els of ni­trosamines. This al­so came as the FDA had re­cent­ly made a ma­jor re­vi­sion to its guid­ance for drug man­u­fac­tur­ing fa­cil­i­ties, not­ing that they must now doc­u­ment ni­trosamines along with ni­trosat­ing agents, ni­trates and azides.
For Au­robindo, the com­pa­ny has re­called sev­er­al prod­ucts this year in­clud­ing mox­i­floxacin oph­thalmic so­lu­tion — an an­tibi­ot­ic used to treat eye in­fec­tions like bac­te­r­i­al con­junc­tivi­tis. In Jan­u­ary, Au­robindo vol­un­tar­i­ly re­called a lot of polymyx­in B for in­jec­tion af­ter a hair was found in a vial with­in the lot.
The com­pa­ny, which has been sub­ject to sev­er­al FDA in­spec­tions, al­so shut down its site in Day­ton, New Jer­sey ear­li­er this year, elim­i­nat­ing 99 jobs in the process.
The sto­ry has been up­dat­ed to re­flect that two batch­es of the drug were re­called. 
On Friday afternoon, the FDA’s oncology drug advisory committee unanimously voted 16-0 against the approval of Y-mAbs’ experimental drug for CNS metastases in pediatric neuroblastoma patients. The key issue the FDA pointed to was that the external control group for Y-mAbs’ pivotal study was very different from the treatment group at baseline, an issue it highlighted in briefing docs released yesterday.
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Digital medicine has become a major component in an ever-evolving healthcare environment. You’re likely already familiar with digital technologies such as telehealth platforms and electronic health records. Plus, there are hundreds of thousands of wellness apps available to anyone on smartphone app stores.
But there’s a reason digital medicine and even more specifically, digital therapeutics exist in a subcategory of their own. A digital therapeutic is typically described as an evidenced-based software solution, which are held to the same standards of regulatory oversight as more traditional medical devices. Digital Therapeutics can positively impact the trajectory of a patient’s disease and are approved to deliver specific clinical outcomes. In other words, Digital Therapeutics are viewed as clinically validated software solutions used by clinicians to treat, manage, and prevent a broad spectrum of diseases and disorders. This differs significantly from consumer health apps that track health or aid in the care process in some way.
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Only a few weeks after the FDA recognized a shortage of Adderall, another crucial drug is in low supply, this time the antibiotic amoxicillin.
According to the American Society of Health System Pharmacists’ (AHSP) drug shortage list, three manufacturers are posting shortages of the oral version of the drug. The list includes Hikma Pharmaceuticals, Teva and Sandoz, which are reporting low supplies of multiple dosage amounts. The companies did not post a reason for the shortages.
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Following the US’ lead, the EMA is cutting back on the use of JAK inhibitors for some patients over a suite of safety concerns.
The EMA’s safety committee issued new guidance on Friday, recommending that a group of JAK inhibitors used for chronic inflammatory disorders are only used in certain at-risk patients if no alternatives are available.
That includes patients 65 years and older, those at risk of major heart problems, those who smoke or who have extensively in the past and those at risk of cancer. Patients at risk of blood clots in the lungs and deep veins (VTE) should take caution, the committee says, while recommending lower doses for some patients at risk of VTE, cancer or major heart problems.
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Alnylam Pharmaceuticals, the pharma market’s leader in RNAi therapies, reported its third quarter earnings Thursday, updating shareholders on its pipeline progress and initial sales figures for the recently approved vutrisiran (marketed as Amvuttra).
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As third quarter numbers rolled in, Sanofi CEO Paul Hudson alluded to the French pharma’s objectives moving forward.
Kicking off a call Friday morning with investors and analysts, Hudson wasted little time when it came to discussing President Biden’s Inflation Reduction Act and its impact on drug prices. Among other things, the Sanofi chief said from his perspective, the implementation of the Act’s drug policies will likely “create significant uncertainties across our industry with regards to sustainable investment in science and innovation, and artificially influence future R&D decisions.” Additionally, he said the bill does not address what he called “core concerns,” specifically around access to certain medicines and affordability.
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The FDA is changing up its marketing rules for emergency use Covid treatments. Six drugmakers can now more broadly promote their Covid therapies, including Pfizer’s Paxlovid and AstraZeneca’s Evusheld.
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Even back in the day as the singer for Chester French, a two-man indie pop group that sporadically flared into public sight with songs like “She Loves Everybody,” DA Wallach had a rep as someone who knew people. Or could get to know them.
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