tofacitinib / Generic mfg. - LARVOL DELTA

Zydus receives final and tentative Approval from the USFDA for Tofacitinib Tablets, 5 mg and 10 mg (Equitybulls) - "Zydus Pharmaceuticals (USA) Inc. has received final approval for Tofacitinib Tablets, 5 mg and tentative approval for Tofacitinib Tablets, 10 mg (USRLD: Xeljanz® Tablets) from the United States Food and Drug Administration (USFDA). Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Tofacitinib Tablets, 5 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Tofacitinib Tablets, 5 mg."

ANDA • Ankylosing Spondylitis • Atopic Dermatitis • Crohn's disease • Hidradenitis Suppurativa • Immunology • Rheumatoid Arthritis • Ulcerative Colitis

Shanghai Pharmaceuticals Unit Gets Regulatory Nod For Anti-Arthritis Drug (Market Screener) - "Shanghai Zhongxi Pharmaceutical...received the approval of China's National Medical Products Administration for its tofacitinib citrate tablets. The drug, which is mainly used to treat patients with rheumatoid arthritis and ankylosing spondylitis, was categorized as Class 4 as it was first developed by Pfizer and launched in the US in 2012."

Non-US regulatory • Ankylosing Spondylitis • Immunology • Rheumatoid Arthritis

Russian drugmaker PSK Pharma launches generic of Pfizer’s tofacitinib (The Pharma Letter) - "The Russian drugmaker PSK Pharma has launched the production of tofacitinib – a generic version of Pfizer’s...Xeljanz/Jaquinus drug, reports The Pharma Letter’s local correspondent. It will be sold under the Tofara brand, according to PSK Pharma’s chief executive Evgenia Shapiro. This drug is used to treat rheumatoid arthritis and is included in the list of vital drugs."

Generic launch • Immunology • Rheumatoid Arthritis

Ministry of Food and Drug Safety approves marketing of four drugs, including Pfizer’s JAK inhibitor generic [Google translation] (Health Korea News) - "The Ministry of Food and Drug Safety approved the marketing of four drugs, including the generic Pfizer's JAK (Janus kinase) inhibitor 'Xeljanz' (ingredient name: tofacitinib)....Samil Pharm received approval for Zacrin Tablet (tofacitinib citrate) 5mg as a prescription drug (generic). This drug is a generic of 'Xeljanz' and is used for autoimmune diseases such as rheumatoid arthritis and psoriatic arthritis..."

Non-US regulatory • Immunology • Psoriatic Arthritis • Rheumatoid Arthritis

Regulator to limit JAK inhibitor's use on older, high-risk patients (Korea Biomedical Review) - "The Ministry of Food and Drug Safety will limit the use of Janus kinase (JAK) inhibitor, a treatment for inflammatory diseases, on older adults and other high-risk groups only when existing treatments prove ineffective....The recent decision follows a safety review conducted after the ministry distributed a drug safety letter in September....The Korean regulator also reviewed the results of recent adverse effects."

Non-US regulatory • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis

High-Dose Tofacitinib Cuts Colectomy Rates For Acute Severe UC - "'If these findings are validated in large, randomized controlled studies, administering high-dose tofacitinib could be a practical and cost-effective alternative strategy for medical salvage in acute severe UC, with strikingly low rates of colectomy compared to current standards of care,' said Dana Lukin, MD, PhD...Given the rapid action of Janus kinase inhibitors, like tofacitinib, and the questionable wisdom of waiting 72 hours before moving from IV corticosteroids to another treatment in high-risk acute severe UC, we investigated a short course of high-dose tofacitinib initiated at the same time as IV steroids,' said Peter Higgins, MD, PhD..."

Clinical • Media quote

"#JustIn | Cadila Health gets tentative @US_FDA nod for arthritis drug, Tofacitinib tablet" (@CNBCTV18Live)

Immunology • Rheumatology

Zydus receives tentative approval from the USFDA for tofacitinib tablets (Zydus Cadila Press Release) - "Zydus Cadila has received the tentative approval from the USFDA to market Tofacitinib Tablets (US RLD – Xeljanz® Tablets), 5 mg...used alone or with other medications (such as methotrexate) to treat moderate to severe forms of rheumatoid arthritis....It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad."

ANDA