Last Updated on November 10, 2025 by The Health Master
USFDA approval
Alembic Pharmaceuticals has made a great stride in the U.S. with the announcement of final U.S. Food & Drug Administration approval (USFDA Approval) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP in 25 mg and 37.5 mg strengths.
Final USFDA approval via ANDA means that Alembic can now be a manufacturer and seller of its generic equivalent of a well-known, life-saving medication.
Generic ANDA USFDA approval is a long process that guarantees to the general public that the marketed version is safe, effective and is absorbed and used in the same manner in the body as its brand name counterpart.
Therapeutically Equivalent and Impact on the Market
According to the USFDA, Alembic’s Paroxetine Extended-Release Tablets USP (25 mg and 37.5 mg) strengths are therapeutically equivalent to the Reference Listed Drug (RLD), Paxil CR Extended-Release Tablets, made by Apotex Inc.
Therapeutically equivalent means that this generic has the same clinical effectiveness as its brand name counterpart; for the consumer, this news is welcomed since a final approval means that the drug will be sold on the market, and typically a generic brings down costs of treatment since there will be increased competition of various manufacturers producing various strengths of the same medicine for patients with chronic indications.
Understanding paroxetine extended-release
Paroxetine Extended-Release is an important medication that falls under the category of Selective Serotonin Reuptake Inhibitors (SSRIs).
ER means it releases the drug over time.
This indicates a safe way to formulate medication delivery since it allows for less frequent dosing and steady state action with potentially less side effects for certain individuals.
This is an important medicine for some difficult-to-treat psychological disorders with approved FDA indications being:
- Major depressive disorder (MDD): A common but serious medical illness that negatively affects how people feel, think and act
- Panic disorder (PD): A psychiatric disorder characterized by recurrent unexpected panic attacks, episodes of intense fear accompanied by symptoms such as chest pain or shortness of breath
- Social anxiety disorder (SAD): Also known as social phobia, intense anxiety or fear of being judged, negatively evaluated or rejected in a social or performance situation
- Premenstrual dysphoric disorder (PMDD): A debilitating form of premenstrual syndrome (PMS) marked by extreme mood changes, irritability and depression
Q: What does ‘Extended-Release’ mean for this medication?
Extended-release (ER) means the tablet releases over time.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
USFDA approval granted for blood clotting drug: Alembic
USFDA puts import Alert on Sun Pharma: Halol
USFDA issued Form 483 to Biocon with 5 observations
USFDA issued Form 483 to Aurobindo with 8 observations
USFDA issued Form 483 to Alembic Pharma with 1 observation
USFDA issued Form 483 with two observations to Aurobindo for API plant
Drug recall: 5 Indian Companies recall drugs over quality issues
India Bans 34 Key Antimicrobials for Animal Use
49 new Drug Inspectors join in CDSCO
USFDA Inspection: At Jubilant with Zero observations
USFDA issued Form 483 to Lupin with 4 observations: Pune
Drug alert: 94 drug samples declared as NSQ in August 2025
USFDA issued Form 483 to Lupin with 6 observations: Nagpur
Haryana: ₹5,000 Crore investment Plan for Pharma and Medical Device
