Drugs
Impax Laboratories has recalled one lot of lamotrigine orally disintegrating tablets (ODT) 200 mg (Lot # 502240) due to a packaging error. The unit-of-use blister packs (a 10-count blister card contained in a single plastic shell-pack) may contain 100 mg product instead of the 200 mg product,
Drugs
Hybrid Pharma (Deerfield Beach, FL) has been cited in an eight-page Form-483 after a July inspection found that the firm had inadequate procedures designed to prevent microbiological contamination of drug products purporting to be sterile. The inspection also found the firm’s aseptic processing deficient regarding the system
Drugs
Illinois attorney general Lisa Madigan has filed a lawsuit against Insys Therapeutics for “deceptively marketing” and selling Subsys, described as a highly addictive opioid drug indicated for treating breakthrough cancer pain. Madigan says the company illegally marketed the pain killer to physicians for treating non-cancer patients for off-label
Drugs
FDA has granted Mallinckrodt a fast track designation for Synacthen Depot (tetracosactide) and its use in treating Duchenne muscular dystrophy. The synthetic 24 amino acid melanocortin receptor agonist is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions. Currently, the first patients have been dosed
Drugs
FDA has granted Biotie Therapies an orphan drug designation for its BTT1023 drug candidate for treating primary sclerosing cholangitis (PSC), which is a chronic and progressive fibrotic liver disease for which there are currently no FDA-approved treatments. The company says BTT1023 is a fully human monoclonal antibody targeting Vascular
Drugs
FDA has granted Lupin Ltd. tentative approval for its ANDA for paroxetine extended-release tablets, 12.5 mg, 25mg and 37.5 mg, generic copies of GlaxoSmithKline’s anti-depressant Paxil CR. “The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues
Drugs
FDA has released a guidance on “Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation” that is intended to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. The guidance finalizes a draft document that was issued 9/2009. The final guidance was
Drugs
FDA has issued a complete response letter for Amgen’s NDA for Parsabiv (etelcalcetide) for treating secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. The company says it is reviewing the letter and anticipates a post-action meeting with the agency later this year to discuss it.
Drugs
Lilly says it will appeal an Indiana federal court ruling that its formulation patent for the testosterone treatment Axiron was invalidated and therefore would not be infringed by commercialization of generic forms of the drug. The court also determined that an underarm applicator patent was valid but also would not
Drugs
CDRH says it is creating a new Pediatric Extrapolation for Devices (PED) team to evaluate and review device submissions that include data extrapolation in seeking pediatric indications. The PED team is part of the Center’s implementation efforts involving a final guidance on “Leveraging Existing Critical Data for Extrapolation to
Drugs
The Biotechnology Innovation Organization (BIO) says that it and its members recognize the importance of understanding and considering the needs and preferences of the patients they serve. “To ensure BIO and its members understand and can thoughtfully address what is most important to patients, their caregivers, and their families, we
Drugs
FDA says it will begin accepting 9/3 Risk Evaluation and Mitigation Strategies (REMS) documents in “structured product labeling (SPL)” formats as a means to standardize the documents and eventually integrate them into electronic healthcare records. Currently, there are 75 approved REMS, with 42 of those having the most restrictive
Drugs
With the huge outcry from media, parents and healthcare professionals on Mylan increasing its EpiPen (epinephrine injection) auto-injector by 400%, lawmakers have written FDA asking what it can do to ensure approval of competitive alternatives. “We are concerned that Mylan has not faced much competition for its product,” the
Drugs
FDA has posted a guidance on “ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits” — that is intended to help applicants preparing to submit ANDAs and prior approval supplements for approval of a new strength of a drug product. The guidance highlights deficiencies about impurities that may
Drugs
Harvard Medical School researchers Arnold Kesselheim, Jerry Avorn, and Arneet Sarpatwarni say that prescription drugs are priced in the U.S. “primarily on the basis of what the market will bear.” Writing in a Journal of the American Medical Association Special Communication (subscription required), the three say that the much
Drugs
A California federal court has rejected a class action case settlement proposed by Similasan Corp. that has been accused of engaging in false and deceptive labeling of their homeopathic products, among other things. Texas attorney general Ken Paxton, who opposed the settlement along with seven other state attorneys general, says
Drugs
The Stericycle Recall Index for the second quarter of 2016 shows that drug recalls are up from the first quarter, but still well below historical trends dating back to 2004. Recalls rose 35% to their highest level since the third quarter of 2014, the report says. And recalled units increased
Drugs
FDA says that Bayer has expanded its 7/21 recall of two lots of its hemophilia A drug Kogenate FS containing active ingredient manufactured before 11/2015 to include eight additional lots. An agency notice says the recall expansion is based on a company analysis of additional lots with active
Drugs
A DC federal court has agreed with an FDA interpretation that the statutory three-year clinical investigation exclusivities prohibits approval of second-in-time applications for a drug with the same active moiety as the drug with the exclusivity. Attorney Nicole Stakleff (Pepper Hamilton) writes in her firm’s online
Drugs
FDA has granted TG Therapeutics an orphan drug designation for its next generation PI3K Delta inhibitor, TGR-1202, for treating patients with chronic lymphocytic leukemia (CLL). TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 trial for patients with both frontline and previously treated CLL. The delta
Drugs
Galapagos and Gilead have begun a Phase 3 clinical trial program called FINCH that will investigate the efficacy and safety of 100 mg and 200 mg filgotinib once daily in rheumatoid arthritis patients. The program includes the following three studies: * FINCH 1 is a 52-week, randomized, placebo- and adalimumab-
Drugs
FDA inspections at Unimark Remedies’ active pharmaceutical ingredient Vapi facility (5/18-5/22/15) and Belva facility (8/3-8/14/15), both in India, found significant deviations from current good manufacturing practice regulations, according to an 8/15 Warning Letter. Specific violations found at the Vapi facility included: