19
Dec
Unofficial Mid-December 2023 OGD Approval Numbers - Lachman Consultants

Unofficial Mid-December 2023 OGD Approval Numbers

Thankfully, it looks like the FDA has been able to address its IT issues, although approvals are now appearing more than a few days after the approval letters are issued. This peek at the numbers is provided for approval information posted as of December 20th – which includes posted approvals through December 15th. As of that date, […]

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19
Dec
CBER Orphan Drug Approvals for 2023 - Lachman Consultants

CBER Orphan Drug Approvals for 2023

According to an updated post on the Center for Biologics Evaluation and Research (CBER) webpage, there were twelve Biologics License Applications (BLAs) approved for products that had orphan drug (OD) status. Just to cite a few: Two were for treatment of sickle cell disease (SCD). One was for enzyme replacement therapy (ERT) in adult and […]

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18
Dec
First-Time Generic Approvals for FY 2023 - Lachman Consultants

First-Time Generic Approvals for FY 2023

The Office of Generic Drugs approved eighty-two first-time generic products in FY 2023 for fifty-two different products. For example, the OGD approved sixteen ANDAs on the same day for Lisdexamfetamine Dimesylate Capsules (the generic for Vyvanse) on August 25, 2023. Each of these is counted as a first approval because they were all approved on the same […]

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13
Dec
First Month FY 2024 OGD Statistics Are Finally Available - Lachman Consultants Blog

First Month FY 2024 OGD Statistics Are Finally Available!

Almost two and a half months after the beginning of FY 2024, the first month of FY 2024 (October 2023) statistics appeared, almost like a Christmas present! And from the looks of the numbers, there is likely some coal in some of the statistical “stockings.” Let’s start with the Original ANDA approval numbers. The OGD did pretty […]

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12
Dec
FDA Says Isotretinoin REMS Should Be Modified - Lachman Consultants Blog

FDA Says Isotretinoin REMS Should Be Modified – You Can Hear the Cheers from Users and Practitioners!

This has been a long time coming! Ever since the first approval of isotretinoin (Accutane – by Hoffmann La Roche, Inc. on May 7, 1982), and the associated safety requirements associated with that product’s labeling, the requirements for the safe use of isotretinoin products have become stricter. This type of safety information and requirements for […]

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05
Dec
Congress Questioning Delayed FDA Action on Phenylephrine - Lachman blog image

Congress Questioning Delayed FDA Action on Phenylephrine – What About Impact on Other Decongestants?

In an article published in Fierce Pharma today (here), Kevin Dunleavy pointed to a congressional letter (here), penned by Congresswoman Lisa McClain, Chairwoman, Subcommittee on Health Care and Financial Services, that questions the long lag time for the FDA and its advisory committee to come to the conclusion that phenylephrine, as an oral decongestant, does […]

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14
Nov

Good News and Bad News re FTC’s Action on Patent Listings

On November 7, 2023, a press release from the FTC announced that “the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” […]

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08
Nov
Cosmetic Facility Registration and Listing Gets 6-Month Reprieve

Cosmetic Facility Registration and Listing Gets 6-Month Reprieve

The FDA issued a guidance today entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (here) announcing a 6-month period during which the FDA will not take compliance actions against a company for failing to meet the cosmetic listing and facility registration requirements. According to the FDA, the policy is designed to […]

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07
Nov
Orphan Drug Preemptive Challenge Strikes at One Aspect of the Orphan Drug Exclusivity Decision Making

Orphan Drug Preemptive Challenge Strikes at One Aspect of the Orphan Drug Exclusivity Decision Making

Sidley Austin LLP filed a petition (here) requesting that FDA not grant orphan drug exclusivity to a ready-to-use version oral solution of vigabatrin. There are currently two versions of vigabatrin already approved with a number of generics available. The original approved NDA products (tablet and power for reconstitution) were granted orphan drug exclusivity (ODE), the […]

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