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FDA Approves Generic Zomig and Zomig-ZMT Tablets
Posted 3 days ago in Pharma Industry News
May 15, 2013 -- The U.S. Food and Drug Administration today approved the first generic versions of Zomig and Zomig-ZMT tablets. Zomig (zolmitriptan) belongs to the class of drugs called triptans, and is indicated for the acute treatment of migraine with or without aura in adults. Zomig was first approved in tablet form in November 1997, and Zomig-ZMT orally disintegrating tablets followed in February 2001 as an alternative for patients who have difficulty swallowing conventional...
Read more...Endo Health Solutions Responds to FDA's Denial of Opana ER Citizen Petition and the Potential Approval of Additional Non-Abuse Deterrent Formulations of Generic Oxymorphone
Posted 5 days ago in Pharma Industry News
MALVERN, Pa., May 10, 2013 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals Inc. Endo presented FDA data collected from an ongoing epidemiology study that indicate that per 100,000 prescriptions dispensed, the past 30-day abuse rate of crush-resistant OPANA ER was 79 percent lower than the abuse rate of generic versions of...
Read more...Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen Containing Protease Inhibitor ABT-450
Posted 1 weeks ago in Pharma Industry News
WATERTOWN, Mass.--May 6, 2013--Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie’s investigational direct-acting antiviral (DAA) combination regimen with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a Breakthrough Therapy by the U.S. Food and Drug...
Read more...Drugs.com Releases Q1 Sales for Top 100 U.S. Drugs: Rough U.S Flu Season Boosts Numbers for Tamiflu
Posted 1 weeks ago in Pharma Industry News
NEW YORK, May 6, 2013 /PRNewswire/ — Drugs.com, the leading online clinical drug resource, today released first quarter 2013 U.S. prescription sales data for the top 100 drugs. The top five drugs have minor shifts in rank but exhibit positive growth for Q1 2013. Abilify, Otsuka’s second generation antipsychotic, and Nexium, AstraZeneca’s leading acid blocker, rank as the top two drugs by sales for the fourth quarter in a row. Both agents hover in the $1.5 billion range for quarterly...
Read more...Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication
Posted 1 weeks ago in Pharma Industry News
Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion AUDIENCE: Risk Manager, Pharmacy, Oncology ISSUE: The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. The dosing and...
Read more...Valproate Anti-Seizure Products: Drug Safety Communication
Posted 1 weeks ago in Pharma Industry News
Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics AUDIENCE: Health Professional, Neurology, Pharmacy, Patient ISSUE: FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products,...
Read more...Hyperion Therapeutics Receives Orphan Drug Exclusivity From FDA
Posted 2 weeks ago in Pharma Industry News
SOUTH SAN FRANCISCO, Calif., May 2, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the U.S. Food and Drug Administration (FDA) yesterday notified the company that RAVICTI(TM) (glycerol phenylbutyrate) Liquid has qualified for orphan drug exclusivity. The orphan exclusivity is for seven years from the date of the approval on February 1, 2013. According to Donald J. Santel, president and chief executive officer, "Orphan drug exclusivity...
Read more...FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
Posted 2 weeks ago in Pharma Industry News
Safety Announcement [04-30-2013] The U.S. Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death. Samsca is used to treat low sodium levels in the blood. An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca for a new use...
Read more...FDA OKs OTC Plan B for 15 and Older
Posted 2 weeks ago in Pharma Industry News
FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older. After the FDA did not approve Teva’s application to make Plan B One-Step available over-the-counter...
Read more...FDA Warns of Fake Botox
Posted 2 weeks ago in Pharma Industry News
Fraudulent Versions of Botox Found in the United States [04-26-2013] FDA is alerting health care practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices. The outer carton is counterfeit, while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States. These products are being sold by unlicensed suppliers who are not part of the legitimate...
Read more...FDA Device to Detect Fake Malarial Drugs
Posted 3 weeks ago in Pharma Industry News
FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3. Malaria kills more than 660,000 people globally each year, mostly children. The threat of...
Read more...Merck Announces Breakthrough Therapy Designation for Lambrolizumab an Investigational Antibody Therapy for Advanced Melanoma
Posted 3 weeks ago in Pharma Industry News
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other...
Read more...Teva Neuroscience Gets FDA Letter Regarding Clozapine Promotion
Posted 3 weeks ago in Pharma Industry News
SILVER SPRING, Md., April 23, 2013-The FDA yesterday posted on its website a letter sent to Teva Neuroscience regarding an article detailer for Clozapine tablets. The letter is below. Carol Childers Director Teva Neuroscience, Inc. 901 East 104th Street, Suite 900 Kansas City, MO 64131 RE: ANDA 076809 Clozapine tablets USP MA# 44 Dear Ms. Childers: The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed an article...
Read more...Sanofi Pasteur and KaloBios Pneumonia Drug Fast-Tracked
Posted 3 weeks ago in Pharma Industry News
U.S. FDA Grants Fast-Track Designation to Sanofi Pasteur and KaloBios' Novel Biologic Candidate for Pseudomonas aeruginosa CHICAGO, April 23, 2013 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), and KaloBios Pharmaceuticals (Nasdaq: KBIO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sanofi Pasteur for the investigation of KB001A, an antibody fragment, intended for...
Read more...FDA recently approved changes to the Atripla
Posted 3 weeks ago in Pharma Industry News
FDA recently approved changes to the Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablet label to include the following changes: • Lists Stribild as one of the drugs that should not be coadministered with Atripla • Adds drug interaction information for raltegravir, boceprevir and telaprevir • Strengthens Warnings and Precautions: Rash section • Updates the Use in Specific Populations: Nursing Mothers section • Updates Tables 7 and 8...
Read more...Balanced Solutions Compounding Pharmacy Issues Voluntary Recall
Posted 3 weeks ago in Pharma Industry News
All sterile non-expired products recalled due to a lack of sterility assurance Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expireddrug products due to a lack of sterility assurance and concerns with product quality controls. Health care facilities and health care providers that have received sterile products from Balanced Solutions should...
Read more...Neura Therapeutik Addresses FDA Concerns about Abuse, Misuse of Drugs with Development of Safe and Affordable Abuse-Deterrent Opioids
Posted 4 weeks ago in Pharma Industry News
FLEMINGTON, N.J., April 18, 2013 /PRNewswire/ -- Neura Therapeutik announced today that they will be accelerating the development of their abuse-deterrent brand and generic extended-release opioids. This is in response to the Food and Drug Administration's recent announcement that they will not approve any generic to the original version of OxyContin® extended release oxycodone. The currently marketed version of OxyContin® possesses abuse-deterrent properties which the original version did...
Read more...Purdue Pharma Statement on FDA Approval of New Label for Reformulated OxyContin and FDA Decision Regarding Withdrawal of Original Formulation Due to Safety
Posted 4 weeks ago in Pharma Industry News
Professional Prescribing Information Now Includes Language Describing Abuse-Deterrence Studies Conducted with the Reformulated Tablets April 16, 2013 – STAMFORD, Conn. – Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved new language for the product label for OxyContin® (oxycodone hydrochloride controlled-release) Tablets CII that describes abuse-deterrence studies conducted with the reformulated tablets. Additionally,...
Read more...FDA Approves Abuse-Deterrent Labeling for Reformulated OxyContin
Posted 4 weeks ago in Pharma Industry News
Agency will not approve generics to original OxyContin April 16, 2013 -- The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting). Additionally, because original OxyContin provides...
Read more...FDA Issues Alert for Sterility Issues for ApotheCure, Inc. and NuVision Pharmacy
Posted 4 weeks ago in Pharma Industry News
FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall SILVER SPRING, Md., April 15, 2013--The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high...
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