Generic Product News - November 2023

Pharmacy TimesNovember 2023
Volume 89
Issue 11

The products include Doxycycline Hyclate Delayed-Release Tablets, Lisdexamfetamine Dimesylate Capsules, Calcium Gluconate in Sodium Chloride Injection, Estradiol Tablets USP

Doxycycline Hyclate Delayed-Release Tablets

From: Lupin

PHTM Retail November 2023 Issue

Compare To: Doryx Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC Delayed-Release Tablets,60 mg and 120 mg

Lupin received FDA approval for doxycycline hyclate delayed-release tablets USP in strengths of 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, according to a company press release. Doxycycline is a tetracycline-class antibacterial that treats infections caused by bacteria. It is indicated for Rickettsial infections, sexually transmitted infections, respiratory tract infections, bacterial infections, ophthalmic infections, and severe acne. Doxycycline is also indicated as an alternate treatment for infections where penicillin is contraindicated. The most common adverse events include nausea, vomiting, diarrhea, and bacterial vaginitis. It also interacts with anticoagulant therapy, penicillin, antacids, oral contraceptives, and antiepileptics.


Lisdexamfetamine Dimesylate Capsules

From: Mallinckrodt

Compare To: Vyvanse

The FDA approved an abbreviated new drug application for lisdexamfetamine dimesylate capsules to treat attentiondeficit/ hyperactivity disorder in patients 6 years and older, according to a press release. The capsules are also indicated for moderate to severe binge-eating disorder in adult patients, according to an FDA press release. Lisdexamfetamine dimesylate capsules will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.


Calcium Gluconate in Sodium Chloride Injection

From: Amneal Pharmaceuticals, Inc

Compare To: Copaxone

The FDA granted approval to an abbreviated new drug application from Amneal Pharmaceuticals, Inc, for calcium gluconate in sodium chloride injection in strengths of 1000 mg/50 mL and 2000 mg/100 mL, according to a company press release. Calcium gluconate in sodium chloride injection, which was on the FDA product shortage list, is indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients. However, calcium gluconate in sodium chloride injection is contraindicated in neonates 28 days or younger who are receiving ceftriaxone. It received an FDA competitive generic therapy designation, indicating that it will have 180-day exclusivity.


Estradiol Tablets USP

From: ANI Pharmaceuticals, Inc

Compare To: Estrace

The FDA approved an abbreviated new drug application from ANI Pharmaceuticals, Inc, for estradiol tablets USP, according to a recent press release. Estradiol tablets are indicated for the treatment of moderate to severe vasomotor symptoms (hot flashes) or vaginal atrophy associated with menopause. During menopause, women lose estrogen, resulting in vaginal changes, bone loss, and hot flashes. The most common adverse events associated with estradiol include gastrointestinal issues, sleep problems, cold symptoms, weight gain, pain, dizziness, and rash. This medication should not be taken when pregnant or if the individual has an allergic reaction.


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