Drugs
Bayer says it has completed a rolling NDA submission to FDA for its investigational prostate cancer drug darolutamide. The company says the submission is based on data from a Phase 3 ARAMIS trial in men with non-metastatic castration-resistant prostate cancer. FDA has given darolutamide a fast track designation.
Drugs
FDA has issued Adamis Pharmaceuticals a Refusal to File letter on an NDA for its sublingual tadalafil product, indicated for treating erectile dysfunction. Upon a preliminary review, FDA determined that the NDA was not sufficiently complete to permit a substantive review, according to the company. The agency requested that Adamis
Drugs
A 6/11-6/14/18 FDA inspection at Proandre SL, a Barcelona, Spain, drug manufacturing facility, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/13 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory
Drugs
A 2/8-3/1/18 FDA inspection at the Pure Source drug manufacturing facility in Doral, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/20 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
On the heels of a critical CBS 60 Minutes report that claimed FDA ignited the current opioid crisis, commissioner Scott Gottlieb says the agency will require opioid manufacturers to conduct long-term studies to evaluate whether the drugs maintain their effectiveness with chronic use. “This is a critical question,” he
Drugs
FDA has released the FDA-483 with two observations it issued following a 12/3-12/14/18 inspection at Aurobindo Pharma Unit 4, Hyderabad, Telangana, India. Specific inspection observations were: * failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
Drugs
FDA has approved a Romeg Therapeutics 505(b)(2) NDA for Gloperba (colchicine) Oral solution, 0.6 mg/5 mL for prophylaxis of gout flares in adults. Gloperba is the first liquid formulation of colchicine approved by FDA for this indication. “Existing therapies do not adequately address the physician’s
Drugs
In a decision that may ultimately affect FDA as well, the 3rd Circuit Court of Appeals has issued a ruling in FTC v. Shire ViroPharma that attorney Jennifer Thomas (Hyman, Phelps & McNamara) says “could set the Federal Trade Commission’s litigation authority back decades.” Writing in her firm’s
Drugs
FDA has released the FDA-483 issued following a 1/7-1/15 inspection at the Dr. Reddy’s Laboratories facility in Andhra, Pradesh, India. The four inspection observations in the report were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Drugs
Pharmaceutical Manufacturing Research Services chief executive Ed Thompson told CBS’s 60 Minutes 2/24 that FDA ignited the current opioid crisis when in 2001, and pressured by Big Pharma, the agency wrongly approved a label expansion for Purdue Pharma’s Oxycontin to be used for chronic, long-term pain
Drugs
FDA has published two draft guidances to help drug developers get agency approval. The first draft guidance, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations,” provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products as part of INDs,
Drugs
FDA has approved a Taiho Oncology NDA for Lonsurf (trifluridine and tipiracil) for treating adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy. Approval was based on data from the global, randomized, Phase 3 TAGS trial evaluating Lonsurf plus best
Drugs
Macleods Pharmaceuticals has recalled one lot of losartan potassium/hydrochlorothiazide 100mg/25mg combination tablets due to an impurity level concern. The recall is due to unacceptable amounts of N-nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited. Last month, an updated FDA
Drugs
A new FDA safety alert warns patients and healthcare professionals about Pfizer’s tofacitinib (Xeljanz, Xeljanz XR) after a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of the drug was used in patients with rheumatoid
Drugs
FDA has granted Imbrium Therapeutics an orphan drug designation for its investigational drug etoposide toniribate, described as a novel topoisomerase II inhibitor intended for treating relapsed refractory biliary tract cancer. Also known as cholangiocarcinoma, biliary tract cancer is a rare disease that starts in the bile ducts. It is the
Drugs
FDA has accepted for review an Alexion Pharmaceuticals supplemental BLA for the use of Soliris (eculizumab) in treating patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin-4 (AQP4) auto antibodies. The submission is supported by data from the PREVENT study in patients with anti-AQP4 auto antibody-
Drugs
FDA commissioner Scott Gottlieb and CDER director Janet Woodcock are defending the agency’s oversight of the generic drug industry to quash any doubt that generics are of lesser quality than branded drugs. In a 2/22 statement, the FDA leaders take exception to recent media reports suggesting FDA has
Drugs
An FDA drug safety review has concluded that an increased risk of death exists with Takeda’s Uloric (febuxostat) compared to another gout medicine, allopurinol. The conclusion is based on results from a safety clinical trial that found an increased risk of heart-related death and death from all causes
Drugs
FDA has approved changes to the prescribing information for Pfizer’s Chantix (varenicline) that specifies that the drug is not recommended for pediatric patients 16 years of age or younger because its efficacy in this population has not been demonstrated. Chantix is a nicotinic receptor partial agonist indicated for use
Drugs
FDA has released a draft guidance on “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products.” The document reflects the agency’s current recommendations on overall development programs to support NRT drug products for smoking cessation and related chronic indications. It focuses on drug development and trial
Drugs
FDA has issued a proposed rule to update regulatory requirements for most sunscreen products in the U.S. The proposed rule is intended to bring nonprescription, over-the-counter sunscreens that are marketed without agency approved applications up to date with the latest science to better ensure that consumers have
Drugs
The Justice Department says four companies and three individuals have agreed to plead guilty to federal criminal charges related to illegally importing and selling $11 million worth of pharmaceutical-grade erectile dysfunction drugs falsely marketed as herbal remedies for men. A department news release also says two new cases were