Petitions

18
Jun
Suitability Petition Metrics - Lachman Blog

Suitability Petition Metrics

Any frequent reader of the Lachman blog is well acquainted with the blog’s affinity for commenting on approval metrics from the Office of Generic Drugs (OGD). Today’s blog will also address metrics, but, in this case, the metrics are related to suitability petitions and are completely unofficial as the OGD has yet to publish or […]

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02
Apr

Ophthalmic Drug Product PSG Publishes Under Unusual Circumstances 

Today, the FDA published a Product Specific Guidance (PSG) with recommendations for establishing bioequivalence of oxymetazoline hydrochloride ophthalmic solution (here).  As we have all recognized through the publication of numerous other PGSs over the last five years, the Agency is moving to BE waivers to establish sameness of the product as well as meet the […]

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07
Mar
Could Benzoyl Peroxide be the Next Nitrosamine Nightmare - Lachman Blog

Could Benzoyl Peroxide be the Next Nitrosamine Nightmare?

Benzoyl Peroxide is the active ingredient in many acne creams, ointments, gels, and combination semi-solid products for the treatment of acne. These products are sold either by prescription or over the counter. Valisure is the same testing lab that uncovered the nitrosamine impurities in Ranitidine products that developed over the expiration dating life of drug […]

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26
Jul

Braille or No Braille, That Was the Question! Now We Have the Answer!

Back on January 30, 2023,  I wrote a blog (here)  concerning a petition that was filed by Vanda Pharmaceuticals regarding a perceived difference in labeling between the brand and generic drug.  In this case (and please see original post to familiarize yourself with the details), the firm claimed that the generic excluded braille from its […]

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19
May

Petition Tests OGD Guidance on Use of Males and Females in BE Study

A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]

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31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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03
May

Is the New Proposed Legislation (S-1462) Regarding ANDA Suitability Petitions as Good as it Sounds?

The ANDA suitability petition process has been languishing for years.  Over the years, we have drafted many posts (here, here, here, here, here, here, here, and here, among others) regarding the FDA’s failing to act on what is a statutorily mandated ninety-day time period for approving or denying an ANDA suitability petition.  Today, I read […]

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