ARTICLES BY CASSANDRA LEGER
FDA Concerned With J&J’s Xarelto Indication For ACS
The FDA recently released a statement regarding the recommended use of Xarelto (Rivaroxaban), an anticoagulant, that if used in patients with Acute Coronary Syndrome (ACS), Xarelto is meant to be used as part of a combination therapy with antiplatelet drugs.
FDA Concerned With Ranbaxy Manufacturing Practices
The FDA recently issued statements with regards to their concerns about the drug manufacturing practices at the Toansa pharmaceutical ingredients factory located in Punjab. The plant is owned by Ranbaxy Laboratories LTD. Currently all of Ranbaxy’s India-based factories are banned by the FDA and the company is not permitted to export any of their medications into the U.S.
Currently, Ranbaxy Laboratories is India’s largest drug manufacturer. According to the FDA statement, if the company does not address the FDA’s concerns about the Toansa plant’s manufacturing practices, it too will be banned from exporting any medicines into the U.S.
ANI Pharmaceutical Enters Into Agreement With Sterling Pharmaceuticals
ANI Pharmaceuticals announced in a press release that it had entered into a fee-for-service agreement with Sterling Pharmaceutical Services.
Sterling, a drug developmental and manufacturing company, has been in the pharmaceutical industry for 8 years. The company’s specialized drug developments are focused around oral and liquid delivery systems.
Commissioner Of FDA Urges Compounding Pharmacies To Register
Dr. Margaret Hamburg, commissioner of the FDA, recently sent a letter to state agencies requesting they encourage compounding pharmacies in their area to adhere to the H.R. 3204: Drug Quality and Security Act, which was signed into law in November 2013 after a devastating meningitis outbreak in 2012.
According to the letter, compounding pharmacies are being asked to register as producers of sterile drugs. This request stems back to 2012, when contaminated steroid pain injections, produced by New England Compounding Center located in Framingham, led to the deaths of 64 individuals and affected over 750 more.
DoP Rejects Wockhardt’s Pricing Review Petitions
The Department of Pharmaceuticals made the decision to reject three review petitions that were filed by Wockhardt, addressing a dissatisfying receipt of their drug prices being fixed by the National Pharmaceutical Pricing Authority. The DoP stated that the Wockhardt Company is required to comply with the regulations fixed by the NPPA.
Isarna Therapeutics Partners With Sanofi To Develop ASO Treatments
Isarna Therapeutics disclosed that it is venturing into a strategic manufacturing deal with Sanofi. According to the venture agreement, Sanofi will be responsible for manufacturing Antisense Oligonucleotide (ASO) compounds, for clinical and commercial applications for the German Isarna Therapeutics Company.
FDA Approves Type-2 Diabetes Medication
In a January 8 press release, the FDA announced it had approved Farxiga. The tablet-form drug has been approved for use in adults suffering from type-2 diabetes which affects 24 million individuals and currently accounts for 90% of individuals with diabetes in the U.S. Patients diagnosed with diabetes are at risk for heart disease, kidney disease, amputations and eyesight loss.
FDA To Review Heart Failure Drug For Approval
The FDA announced a new plan to review and evaluate Serelaxin, a new injection based medication by Novartis, designed to treat heart failure. The FDA’s Cardiovascular and Renal Drugs Advisory Committee will begin reviewing the drug, including its Biologics License Application (BLA), on February 13, 2014. A notice for the planned review is available for viewing on the Federal Register, however, the FDA has yet to post the information on their website.
FDA Combats National Fungal Meningitis Facility Contamination
The FDA has issued the Guidance for Industry, a new regulation requesting voluntary registration of all outsourcing facilities on the FDA website. This new process will require compounding facilities to declare all of the compounds they work with, including information regarding their strength, unit amount, National Drug Code (NDC) of active ingredients, as well as pharmaceutical info for the finished product.
FDA Approves First Dual Bronchodilator COPD Treatment
The FDA announced its approval of Anoro Ellipta, a new dry powder inhaler developed for daily use to treat Chronic Obstructive Pulmonary Disease (COPD). It is a combination of umeclidinium bromide and vilanterol, both bronchodilators. It is so new that GlaxoSmithKline has yet to publish pharmaceutical information on this product.