Generics

Pharmacy shelves with various medications.

Hikma pauses generic Advair Diskus launch

Following the FDA's approval of Hikma’s ANDA for generic Advair Diskus in December 2020, Hikma has submitted an amendment to its application to the FDA which reflects enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA application.

A pharmacist preparing a prescription in a bottle.

Sun Pharma intros 2 generics

Sun Pharma is launching docetaxel injection and relaunching its valacyclovir tablets.

Teva launches generic NuvaRing

Etonogestrel and ethinyl estradiol vaginal ring products had a market value of more than $837 million, according to IQVIA November 2020 data.

Viatris’ Avastin biosimilar faces delay

The Food and Drug Administration has informed Biocon Biologics and Mylan, a subsidiary of Viatris, of a deferred action on the biologics license application for MYL-14020, a biosimilar to Roche's Avastin (bevacizumab).

Amneal to acquire most of Kashiv Specialty

With its acquisition of Kashiv Specialty, Amneal will gain a pipeline of 505(b)2 branded products primarily in neurology and endocrinology, as well as a pipeline of complex generics.

Alembic intros generic Timoptic-XE ophthalmic gel-forming solution

Alembic's Timolol Maleate Ophthalmic Gel Forming Solution provides treatment for elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

White tablets spilling out of a prescription bottle.

Dr. Reddy’s intros generic Uloric

The Uloric brand and generic had a market value of approximately $108 million for the most recent 12 months ended October 2020, according to IQVIA.

Amneal launches generic Zytiga in new dosage strength

The Food and Drug Administration approved Amneal’s abiraterone acetate tablets in a dosage strength of 500 mg.

Sun Pharmaceutical intros generic Concerta

Sun Pharmaceutical's methylphenidate hydrochloride ER tablets are available in four dosage strengths.

Lupin gets FDA OK for generic Bactrim

Sulfamethoxazole and trimethoprim oral suspension has a market value of approximately $19 million.

A hand signing a document that another hand is holding.

Slayback Pharma gets $50 million investment from The Everstone Group

The Everstone Group is investing up to $50 million in Series B funding to expand and accelerate Slayback's pipeline of complex generic and specialty pharmaceutical products.

Par launches authorized generic of Amitiza

Amitiza had a market value of approximately $427 million for the 12 months ended Sept. 30, 2020, according to IQVIA.

FDA gives nod, tentative OK to Glenmark’s 3 generics

The Mahwah, N.J.-based company has received approval or tentative approval for generics of Otezla, Cialis and Horizant.

Biocon intros tacrolimus capsules

Biocon's tacrolimus capsules reduces the body’s ability to reject a transplanted organ.