How would you like to spend a couple of hundred thousands of dollars (or equivalent local currency) and countless months getting FDA approval and patent expiration and then face 14 competitors? What’s the ROI for that? June 1, 2011 Donepezil Hydrochloride Tablets, Matrix Laboratories Ltd., Approval Donepezil Hydrochloride Tablets, Cipla Ltd., Approval Donepezil Hydrochloride Tablets, Wockhardt [...]
Archive for the 'ANDA’s' Category
Why generic companies might like 505(b)(2)
Published June 2nd, 2011 in ANDA's and News Commentary. 0 CommentsOphthalmics: 21 CFR 314 94(a)(9)(iv) no longer applies
Published June 2nd, 2011 in 505(b)(2) Process, ANDA's and Formulation Issues. 0 CommentsWho would have guessed that 21 CFR 314.94(a)(9)(iv) no longer applies to ophthalmics? You wouldn’t generally have expected it to just be cancelled – normally FDA must go through notice and comment, but apparently the FDA can make a regulation disappear by decree. 21 CFR 314(a)(9)(iv) states: (iv)Inactive ingredient changes permitted in drug products intended [...]
Approvals of ANDAs slows
Published February 21st, 2011 in ANDA's, Events and News Commentary. 0 CommentsI attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are slowing and there is a growing awareness that the root cause is not just the Office of Generic Drugs (OGD). As [...]
Injectables: 505j or 505(b)(2)?
Published February 1st, 2011 in 505(b)(2) Issues, ANDA's and Formulation Issues. 0 CommentsGeneric injectable drug products are treated differently than other routes of administration when it comes to permitted differences from the RLD. For most dosage forms, the sponsor is allowed to change excipients as long as the test product is bioequivalent to the RLD. No so for injectables, the excipients must be the same. If the [...]
REMS for 505(b)(2) products?
Published January 19th, 2011 in 505(b)(2) Issues, ANDA's and News Commentary. 0 CommentsCamargo has been involved in the development of several opioids and is often contacted by new sponsors to develop alternate formulations. One question often brought up is: does a 505(b)(2) approved opioid require a REMS (Risk Evaluation and Mitigation Strategies — for more information on REMS see a previous posting)? The short answer is: of [...]
Will We Have Generic User Fees? Public Meeting To Be Held.
Published August 23rd, 2010 in ANDA's and Events. 0 CommentsOn the new drug side we have had user fees since 1992. The Prescription Drug User Fee Act (PDUFA) has been renewed many times. The Act provides that FDA will adhere to certain goals in return for fees levied on industry. The pharmaceutical industry has benefited from PDUFA in greater certainty of the timeframe for [...]
Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?
Published August 23rd, 2010 in 505(b)(2) Issues, ANDA's and News Commentary. 0 CommentsLannett Co., Inc. and its subsidiary Cody Laboratories manufacture Morphine Sulfate Immediate Release Concentrated Oral Solution 20mg/mL. Readers will remember that the various manufacturers of morphine solution were the first to receive FDA enforcement letters based on the Agency’s Unapproved Drugs Initiative. Roxane Laboratories filed an NDA for its product which was approved January 25, [...]
I attended the Annual GPhA meeting this past week. This event is attended by the CEO’s and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from the FDA Commissioner, Dr. Margaret Hamburg. In her remarks, Dr. Hamburg admitted to a need for FDA to step up [...]
Can and Should ANDA Labeling Differ from the RLD?
Published February 11th, 2010 in ANDA's and News Commentary. 0 CommentsIn the past two months, two appellate courts, the Fifth Circuit and the Eighth Circuit have handed down decisions which essentially state that generic pharmaceutical companies can be sued in state courts for failure-to-warn regarding serious side effects, where the generic companies had conformed their labeling to that of the current Reference Listed Drug. For [...]
Stability Changes coming to ANDAs
Published October 4th, 2011 in ANDA's and News Commentary. 0 CommentsThis post comes from D.C. where I am attending the GPhA Fall Technical Conference. We just completed a presentation by FDA’s Glen Smith. He detailed the proposed new stability requirements for ANDA drug products. It is essentially the adoption of ICH Q1A. For readers of this blog, we know that 505(b(2) NDA’s must have 12 months [...]