USFDA gives approval for Amphetamine capsules

Mixed salts of single-entity Amphetamine ER capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

USFDA Approval

Last Updated on January 26, 2023 by The Health Master

Hyderabad (Telangana): Granules India announced on Tuesday that the US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by its US subsidiary, Granules Pharmaceuticals, Inc. (GPI), for Amphetamine mixed salts used for treating attention disorder.

Amphetamine is bioequivalent to the reference listed drug product (RLD), Adderall XR extended-release capsules of Takeda Pharmaceuticals.

This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia, and is expected to be launched shortly, according to a company statement shared with stock exchanges.

An abbreviated new drug application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.

Priyanka Chigurupati, Executive Director, GPI, said, “We are pleased to receive the approval of Amphetamine Mixed Salts ER Capsules within 10-months of ANDA filing, which is an extended-release dosage form of a controlled substance (C-II).”

Mixed salts of single-entity Amphetamine ER capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

The company added Granules now have a total of 53 ANDA approvals from USFDA with 51 final approvals and two tentative approvals.

The current annual US market for Amphetamine mixed salts ER capsule product is approximately USD 1.56 billion, according to MAT Nov 2022, IQVIA/IMS Health.

Granules India, incorporated in 1991, is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad with modern facilities.

The pharmaceutical company has manufacturing units of the entire value chain – from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).

The company has seven manufacturing facilities out of which six are located in India and one in the US.

USFDA gives tentative approval Acalabrutinib capsules, 100 mg

USFDA gives tentative approval for Dolutegravir and Rilpivirine tablets

USFDA gives tentative approval for Levomilnacipran extended-release capsules

USFDA gives approval for Febuxostat tablets

USFDA gives approval for Prasugrel tablets

USFDA approves Fesoterodine Fumarate Extended-Release tablets

USFDA issues warning letter to Torrent Pharma for Gujarat facility

Rx: Amazon launches subscription Prescription Drug service

IPA: Pharmacists to become vaccinators

IPC 2023: These resolution passed in IPC 2023

ICMR issues guidelines for Umbilical Cord Blood Banking

CDSCO panel gives nod for Phase III Clinical Trial of FDC Salicylic Acid Plus Luliconazole

Medical store owner nabbed for selling spurious drugs

BA / BE Studies: Bioavailability & Bioequivalence

Drug alert: 70 out of 1375 samples declared as NSQ in December 2022

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon
YouTube Icon