Bob Pollock, Author at Lachman Consultant Services, Inc.

Firm Wastes No Time Trying to Copy Weight Loss Drug

By Bob Pollock Apr 30, 2014 FDA Generics Regulatory Affairs

The first ANDA for Vivus’s diet drug Qsymia (phenteramine hydrochloride and topiramate) appeared in today’s Paragraph IV new postings. The Paragraph IV database is where first-to-file ANDAs containing Paragraph IV challenges to the reference listed drug are posted. The receipt date reported on the FDA site is July 18, 2013, which is just 6 days more than a year since Qsymia was approved (July 12, 2013).

Qsymia is an extended-release product; thus, the turnaround for generic development, generation of required stability data, conduct of successful bioequivalence studies and putting the ANDA together was almost as much time as FDA took to decide the ANDA was acceptable for receipt (almost 10 months).

Apr

To Register or Not to Register – Compounding Pharmacy Dilemma

By Bob Pollock Apr 29, 2014 Compliance FDA Regulatory Affairs

For Compounding Pharmacies, there is a new law (Compounding Quality Act) and a sheriff (the FDA) to enforce the law. The new law is an amendment to the Food, Drug & Cosmetic Act (FDCA), which (amongst other things) requires that the drugs must be compounded in compliance with Current Good Manufacturing Practices (CGMP) by or under direct supervision of a licensed pharmacist in a registered facility.

Under this new law, some compounding pharmacies will be categorized as “outsourcing facilities”. Those pharmacies that compound sterile drugs, among others, must register with the FDA as an “outsourcing facility”.

Apr

Guess What? It’s Almost Time to Self-Identify under GDUFA for FY 2015

By Bob Pollock Apr 29, 2014 Compliance FDA Generics Regulatory Affairs

Just when you thought you got it all done, it is time to do it all over again. FDA announced that the new self-identification for facilities named in a generic drug application will begin again soon.

Apr

Orphan Drug Exclusivity and Monoclonal Antibodies

By Bob Pollock Apr 24, 2014 FDA Regulatory Affairs

Are you thinking of making a monoclonal antibody and hoping that your product is different enough than another already approved to gain 7 years of Orphan Drug Exclusivity (ODE)?

Apr

Ready, Get Set, GO! OGD’s Move to White Oak Starts Next Week

By Bob Pollock Apr 23, 2014 FDA Generics Regulatory Affairs

Had trouble getting hold of someone at the Office of Generic Drugs (OGD) lately? Just wait until next week! The long awaited OGD move to White Oak starts next week and will stretch over at least three weeks.

Apr

37 Compounding Pharmacies Currently Registered as Outsourcing Facilities

By Bob Pollock Apr 18, 2014 Compliance FDA Regulatory Affairs

As of April 11, 2014, the FDA has received and processed requests for 37 compounding pharmacies as outsourcing facilities. In October 2014, outsourcing facilities will be required to pay a fee. The fee schedule will be published in August 2014, and any facility that registers on or after fees are due will have to pay the registration fee at the time of registration.

Apr

MDI and Dose Counters – FDA Reaffirms Position

By Bob Pollock Apr 16, 2014 Compliance FDA Generics Regulatory Affairs

On April 10, 2014, FDA responded to a petition from Teva Respiratory LLC approving it in part and denying it in part. Teva requested that FDA refuse to approve any rescue inhaler (generally metered dose inhalers (MDIs) of short-acting beta agonist like albuterol), brand or generic, unless it has a dose counter, and that FDA implement a plan to transition all currently approved rescue inhalers to versions incorporating a dose counter.

Apr

Half Way Through FY 2014 – A Look at ANDA Submissions and Approvals

By Bob Pollock Apr 15, 2014 FDA Generics Regulatory Affairs

Six months into Fiscal Year 2014 and some staggering submission numbers should send a chill up the old OGD spine. So far, this FY OGD has received 597 new original ANDAs based on numbers released on April 11, 2014. That number reflects activity through the end of March 2014. On the other hand, OGD has approved 392 ANDAs in the first 6 months of this FY. So let’s look at the numbers a bit more closely.

Apr

OMG – Omega -3 ANDA Gets Approved!

By Bob Pollock Apr 14, 2014 FDA Regulatory Affairs

OGD approved another “complex” drug product and brings a happy closure to an ANDA submitted in November 2008. By no means a record in terms of length of approval, this ANDA has been percolating for 65 months since submission and represents another in a string of complex products that OGD has tackled and approved. Thus, the first generic for Lovaza will likely hit the market soon as Teva’s ANDA # 091028 for Omega-3 – Acid Ethyl Esters gained approval on April 7, 2014.

Apr

Big Decisions Loom in 2014 for Generic Applicants

By Bob Pollock Apr 13, 2014 FDA Generics Regulatory Affairs

There are a number of dilemmas looming over generic drug firms in 2014 – some with no easy answers, but hopefully firms are considering their choices sooner rather than later. Two of these issues relate to the all-important question “Exactly when should the ANDA be submitted?”. Any generic drug firm knows that that answer is never easy and is dependent on many factors, such as biostudy success, completion of stability testing, facilities being ready for inspection and first-to-file opportunities, just to name a few. And of course, such practical scientific or regulatory deadlines are further complicated by the directed business goal of “the sooner the better”.