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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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NDA PA32540, Pozen Submits NDA for Aspirin Alternatives
PA32540
PA-325/40 (EC-ASA 325 mg + IR omeprazole 40 mg)
enteric-coated aspirin (EC-ASA) 325 mg
MAR 27,2013
Pozen Inc. announced the submission of a new drug application to the U.S. Food and Drug Administration for the marketing approval of two potential cardiovascular drugs.
The move is a major step toward commercializing the drugs and means that the company thinks it has proven that the drugs are safe and effective.
Pozen’s PA32540 and PA8140 are both intended as alternatives to plain aspirin for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers.
Pozen’s drugs contain aspirin and the omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.
Pozen is seeking approval for use in patients at risk of aspirin-induced ulcers.
Pozen CEO John Plachetka called the move “an important milestone for the drug” and said the company looks forward to completing a commercial deal with a partner “in the upcoming months.”
Pozen’s PA-325/40 is a combination pill containing enteric-coated aspirin 325 mg surrounded by a pH-sensitive film surrounded by an immediate-release omeprazole 40 mg.
Morphine and oxycodone Dual-Opioid combination (MoxDuo)
SYDNEY and BEDMINSTER, N.J., March 14, 2013
QRxPharma Limited announced today the US Food and Drug Administration (FDA) has set 26 August 2013 as the Prescription Drug User Fee Act (PDUFA) date for action on the Company’s resubmitted MoxDuo New Drug Application (NDA).
“We are pleased that the FDA has formally accepted our resubmitted MoxDuo NDA” said Dr. John Holaday , Managing Director and Chief Executive Officer, QRxPharma. “We expect the Advisory Committee meeting to be scheduled between late June and late July and will update shareholders once formal notification has been received,” added Holaday.
The NDA is the basis for recommencing the regulatory approval process for MoxDuo for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US. MoxDuo, an immediate release Dual Opioid® pain therapy, is a patented 3:2 fixed ratio combination of morphine
and
oxycodone
FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA.
NDA FDA-Nuvo reports FDA response to PENNSAID 2% , diclofenac sodium topical solution, 2% w/w
DICLOFENAC
PENNSAID 2%
7 MAR 2013
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Nuvo Research’s US licensing partner, Mallinckrodt, following the review of Mallinckrodt’s New Drug Application (NDA) for diclofenac sodium topical solution, 2% w/w (PENNSAID 2%).
FDA in the letter mentioned that it requires Mallinckrodt’s complete pharmacokinetic study comparing PENNSAID 2% to original PENNSAID 1.5%.
FDA denied to review the similar pharmacokinetic studies submitted by Mallinckrodt with the NDA, as the reserve samples were not retained at the clinical site.
Pharmacokinetic studies are standard studies conducted during a drug development program to identify the total exposure or the amount of drug that reaches the blood stream after a patient receives both single and multiple doses of the product.
Mallinckrodt has suggested Nuvo that it expects to complete the study and submit the results to the FDA in the third quarter of 2013, and that it anticipates the FDA will provide a formal response to the filing within 6 months thereafter.
Nuvo’s Pain Group president Dr. Bradley Galer said with the new FDA’s letter the firm was disappointed that PENNSAID 2% will not be approved in this review cycle.
“We are pleased that the FDA has outlined a clear pathway to approval that we believe can be completed in a relatively short time frame,” Galer added.
“Upon approval, PENNSAID 2% will be the first and only topical NSAID in the U.S. featuring twice per day dosing and a metered dose pump bottle.”
NDA-US Marketing by Ranbaxy, Alembic has announced that it has received an NDA approval for extended release version of Pfizer’s anti depressant drug Pristiq, Desvenlafaxine Base
DESVENLAFAXINE
read at
5 march 2013
Alembic has announced that it has received an NDA approval for extended release version of Pfizer’s anti depressant drug Pristiq. Pristiq sell approximately $550m in the US. Alembic has outlicensed rights to Ranbaxy for marketing in the US. The company will start marketing the product immediately.
Alembic will manufacture and supply the drug to Ranbaxy for marketing in the US. Vadodara-based pharma player, Alembic Pharmaceuticals Limited has received the approval from the US Food and Drug Administration (USFDA) for a bioequivalent version of Pristiq by Pfizer.
NDA –Sefelsa (gabapentin) Extended Release Tablets – formerly Serada
GABAPENTIN
Sefelsa (gabapentin) Extended Release Tablets – formerly Serada
Company: Depomed, Inc.
Treatment for: Menopausal Hot Flashes
Sefelsa (gabapentin) is an investigational extended-release formulation of gabapentin in development for the treatment of menopausal hot flashes.
- Depomed Provides Update on Sefelsa FDA Advisory Committee – March 4, 2013
- Depomed Announces Serada NDA Acceptance and FDA Advisory Committee Meeting – October 15, 2012
- Depomed Announces Submission Of Serada NDA – August 17, 2012
- Depomed Announces Intent to File NDA for Serada for Treatment of Menopausal Hot Flashes – April 18, 2012
NEWARK, Calif., March 4, 2013
Depomed, Inc., a specialty pharmaceutical company, announced today that the Reproductive Health Drugs Advisory Committee (RHDAC) of the U.S. Food and Drug Administration (FDA) voted 2-12 against approval for Sefelsa, Depomed’s investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to menopause. Sefelsa is the proposed trade name for the medication and was formerly referred to as Serada. Based on the outcome of committee meeting, the company will not have a conference call today as previously indicated.
“Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with a growing franchise of treatments for pain and potentially other CNS indications. With revenues from two marketed products, Gralise and Zipsor, significant royalty income from our partnered products and technology, a strong balance sheet and potential to turn cash flow positive in the second half of this year, we believe that 2013 has the potential to be a landmark year in our company’s history,” said Jim Schoeneck, President and Chief Executive Officer of Depomed. “We recognize and appreciate the concerns that were raised by the members of the Advisory Committee. Based on today’s meeting we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high. Until we believe there is a positive direction for Sefelsa, we will cease all spending relating to the product candidate.”
Data presented at today’s Advisory Committee Meeting included results from the Phase 3 clinical program, which enrolled 1706 patients in three studies.
The FDA will consider the Advisory Committee recommendation in its review of the New Drug Application (NDA) for Sefelsa that Depomed submitted on July 31, 2012, though the FDA is not bound to follow it. The Prescription Drug User Fee Act (PDUFA) date for Sefelsa is May 31, 2013. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
About Vasomotor Symptoms
Vasomotor symptoms include hot flashes and night sweats. A hot flash is a sudden flushing and sensation of heat caused by dilation of skin capillaries. Currently, the leading prescription drug product for the treatment of hot flashes associated with menopause is hormone replacement therapy (HRT). HRT involves the administration of the hormone estrogen, either alone or in combination with the hormone progestin.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
Gabapentin (Neurontin) is a pharmaceutical drug, specifically a GABA analog. It was originally developed for the treatment of epilepsy, and currently is also used to relieve neuropathic pain. There are, however, concerns regarding the quality of the trials conducted for a number of conditions.[1]
Web Site: http://www.depomed.com
- Vedula, SS; Bero L; Scherer RW; Dickersin K (November 2009). “Outcome reporting in industry-sponsored trials of gabapentin for off-label use”. The New England Journal of Medicine 361 (20): 1963–71. doi:10.1056/NEJMsa0906126. PMID 19907043.
- “Gabapentin”. The American Society of Health-System Pharmacists. http://www.drugs.com/monograph/gabapentin.html. Retrieved 3 April 2011.
- Vedula, SS; Bero L; Scherer RW; Dickersin K (November 2009). “Outcome reporting in industry-sponsored trials of gabapentin for off-label use”. The New England Journal of Medicine 361 (20): 1963–71. doi:10.1056/NEJMsa0906126. PMID 19907043.
- Moore, RA; Wiffen PJ; Derry S; McQuay HJ (2011-03-16). Moore, R Andrew. ed. “Gabapentin for chronic neuropathic pain and fibromyalgia in adults”. Cochrane database of systematic reviews (Online) (3): CD007938. doi:10.1002/14651858.CD007938.pub2. PMID 21412914.
- Ho, KY; Gan TJ; Habib AS (2006-12-15). “Gabapentin and postoperative pain–a systematic review of randomized controlled trials”. Pain 126 (1–3): 91–101. doi:10.1016/j.pain.2006.06.018. PMID 16846695.
Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem (gadoterate meglumine)
| Cas No. | 98059-18-8 |
| Name | 2-[4,7-bis(carboxylatomethyl)-10-(carboxymethyl)-1,4,7, 10-tetrazacyclododec-1-yl]acetate; gadolinium(3+); (2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol |
Dotarem (gadoterate meglumine)
Company: Guerbet
Treatment for: Diagnostic
Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent under review for use in magnetic resonance imaging (MRI).
VILLEPINTE, France, Feb. 14, 2013 Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age.
Dotarem is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity. The Guerbet NDA recommended dose is 0.1 mmol Gd/kg.
Gadoteric acid
Gadoteric acid (trade names Artirem, Dotarem) is a macrocycle-structured gadolinium-based MRI contrast agent. It consists of the organic acid DOTA as a chelating agent, and gadolinium (Gd3+), and is used in form of the meglumine salt.[1] The drug is approved and used in a number of countries worldwide.[2]
References
- Herborn, C. U.; Honold, E.; Wolf, M.; Kemper, J.; Kinner, S.; Adam, G.; Barkhausen, J. (2007). “Clinical Safety and Diagnostic Value of the Gadolinium Chelate Gadoterate Meglumine (Gd-DOTA)”. Investigative Radiology 42 (1): 58–62. doi:10.1097/01.rli.0000248893.01067.e5. PMID 17213750. edit
- Drugs.com: Gadoteric Acid
A gadolinium chelate paramagnetic contrast agent. When placed in a magnetic field, gadoterate meglumine produces a large magnetic moment and so a large local magnetic field, which can enhance the relaxation rate of nearby protons; as a result, the signal intensity of tissue images observed with magnetic resonance imaging (MRI) may be enhanced. Because this agent is preferentially taken up by normal functioning hepatocytes, normal hepatic tissue is enhanced with MRI while tumor tissue is unenhanced. In addition, because gadobenate dimeglumine is excreted in the bile, it may be used to visualize the biliary system using MRI.
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